VaccinesPhase 4NCT03548337

Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India

A Phase 4 study testing 13vPnC in people with Vaccines, run by Pfizer at 7 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A Phase 4 Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India Read more about this study

Who is it for?: Ages 42 to 72 daysHealthy volunteers can take part
Conditions the study is for: Vaccines
What is being tested?: 13vPnC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 301 participants
Where: 7 sitesIndia
Study dates: 31 May 2018to 20 Dec 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 42 to 72 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian(s) has/have been informed of all pertinent aspects of the study.
Parent(s)/legal guardian(s)/caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Aged 6 weeks (42 to 72 days) at the time of vaccination. (The day of birth is considered Day 0.)
Available for the entire study period and whose parent(s)/legal guardian(s)/caregiver(s) can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Weight of 3.0 kg or greater at the time of vaccination.

Who cannot join

Infant who is a direct descendant (child, grandchild) of
Investigator site staff members directly involved in the conduct of the study, or
Site staff members otherwise supervised by the investigator, or
Pfizer employees directly involved in the conduct of the study.
Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
Previous vaccination with licensed or investigational pneumococcal conjugate vaccine.

Show all 13Show fewer

A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with pneumococcal conjugate vaccine, or any other vaccine or vaccine component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression, including known human immunodeficiency virus infection.
Major known congenital malformation or serious chronic disorder.
Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb's palsy.
Other acute or chronic medical condition including recent laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis).

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

India7 sites

B. J. Medical College & Civil Hospital
Ahmedabad, Gujarat, 380016
Manipal Hospital
Bengaluru, Karnataka, 560017
Sri Ramachandra Hospital
Chennai, Tamil Nadu, 600116
Kanchi Kamakoti Childs Trust Hospital
Chennai, Tamil Nadu, 600034
Sir Ganga Ram Hospital
New Delhi, 110060
KEM Hospital Research Centre
Pune, Maharashtra, 411 011
Bharati Vidyapeeth University Medical College
Pune, Maharashtra, 411043

Other trials in India

About this study

Official title: A PHASE 4, RANDOMIZED, OPEN-LABEL TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13- VALENT PNEUMOCOCCAL CONJUGATE VACCINE FORMULATED IN MULTIDOSE VIALS WHEN GIVEN WITH ROUTINE PEDIATRIC VACCINES IN HEALTHY INFANTS IN INDIA

Read the detailed description

A Phase 4, Randomized, Open-label Trial To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India

Conditions: Vaccines
Being tested: 13vPnC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

13vPnCBiological
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative

Study groups in NCT03548337
Study group	Role	What they receive
13vPnC with 2-PE from a MDV	Active comparator	Multi Dose Vial with preservative Receives: Biological: 13vPnC
13vPnC without 2-PE in a PFS	Active comparator	Pre Filled Syringe without preservative Receives: Biological: 13vPnC

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 centimeters [cm]), moderate (2.5 to 7.0 cm) and, severe (greater than [>] 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Measured: Within 7 days after Vaccination 1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability,were recorded daily using an electronic diary. Fever graded as:1)less than (<)38.0 degrees Celsius [C], 2)greater than or equal to(>=)38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as:mild(increased or prolonged sleeping bouts), moderate(slightly subdued; interfering with daily activity), and severe(disabling; not interested in usual daily activity). Irritability graded as: mild(easily consolable), moderate(required increased attention), and severe(inconsolable; crying could not be comforted). Participants may be represented in >1 row. Here,"Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Measured: Within 7 days after Vaccination 1
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Measured: Within 7 days after Vaccination 2
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) < 38.0 degrees C, 2) >= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in >1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Measured: Within 7 days after Vaccination 2
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Measured: Within 7 days after Vaccination 3
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) < 38.0 degrees C, 2) >= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in >1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Measured: Within 7 days after Vaccination 3
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Measured: Within 7 days after Vaccination 4
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) < 38.0 degrees C, 2) >= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in >1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Measured: Within 7 days after Vaccination 4
Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Measured: From Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months)
Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Measured: From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month)
Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months)
Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4
A newly diagnosed chronic medical condition was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months)

Secondary outcomes (8)

Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Percentage of participants achieving predefined antibody threshold: >=0.35 microgram per milliliter (mcg/mL) for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F; threshold >= 0.23 mcg/mL for serotype 5, threshold >= 0.10 mcg/mL for serotype 6B, threshold >= 0.12 mcg/mL for serotype 19A, along with the corresponding 95 percent (%) confidence interval (CI) are reported.
Measured: 1 month after Vaccination 3
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F, threshold >= 0.23 mcg/mL for serotype 5, threshold >= 0.10 mcg/mL for serotype 6B, threshold >= 0.12 mcg/mL for serotype 19A, along with the corresponding 95% CI are reported.
Measured: 1 month after Vaccination 4
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported.
Measured: 1 month after Vaccination 3
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported.
Measured: 1 month after Vaccination 4
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs.
Measured: 1 month after Vaccination 3
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs.
Measured: 1 month after Vaccination 4
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Percentage of participants achieving OPA titer >=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13.
Measured: 1 month after Vaccination 3
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Percentage of participants achieving OPA titer >=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13.
Measured: 1 month after Vaccination 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 201820 Dec 2019

First posted7 Jun 2018
Study start31 May 2018
Primary completion20 Dec 2019
Study completion20 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for VaccinesStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03548337
Sponsor's protocol ID: B4671004
Other IDs: INDIA INFANT MDV, 2016-005134-29, 2016
Status last verified: Sep 2020
First submitted: 22 May 2018
Last updated: 30 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Lalwani SK, Ramanan PV, Sapru A, Sundaram B, Shah BH, Kaul D, Karthik Nagesh N, Kalina WV, Chand R, Ding M, Suroju S, Scott DA, Lockhart SP. Safety and immunogenicity of a multidose vial formulation of 13-valent pneumococcal conjugate vaccine administered with routine pediatric vaccines in healthy infants in India: A phase 4, randomized, open-label study. Vaccine. 2021 Nov 5;39(46):6787-6795. doi: 10.1016/j.vaccine.2021.09.029. Epub 2021 Oct 14.
PubMed 34656378

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 4, RANDOMIZED, OPEN-LABEL TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13- VALENT PNEUMOCOCCAL CONJUGATE VACCINE FORMULATED IN MULTIDOSE VIALS WHEN GIVEN WITH ROUTINE PEDIATRIC VACCINES IN HEALTHY INFANTS IN INDIA
ClinicalTrials.gov ID: NCT03548337
Acronym / sponsor ID: B4671004
Conditions: Vaccines
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 31 May 2018 (actual)
Primary completion: 20 Dec 2019 (actual)
Study completion: 20 Dec 2019 (actual)
First posted: 7 Jun 2018 (actual)
Results: Posted 30 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
13vPnC with 2-PE from a MDV	Active comparator	Biological: 13vPnCMulti Dose Vial with preservative
13vPnC without 2-PE in a PFS	Active comparator	Biological: 13vPnCPre Filled Syringe without preservative

Who may qualify

Ages: 42 to 72 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian(s) has/have been informed of all pertinent aspects of the study.
Parent(s)/legal guardian(s)/caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Aged 6 weeks (42 to 72 days) at the time of vaccination. (The day of birth is considered Day 0.)
Available for the entire study period and whose parent(s)/legal guardian(s)/caregiver(s) can be reached by telephone.
Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Key exclusion criteria (13 listed)

Infant who is a direct descendant (child, grandchild) of
Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
Previous vaccination with licensed or investigational pneumococcal conjugate vaccine.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with pneumococcal conjugate vaccine, or any other vaccine or vaccine component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
13vPnC13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative	Biological	13vPnC with 2-PE from a MDV, 13vPnC without 2-PE in a PFS

Primary outcome

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Time frame: Within 7 days after Vaccination 1
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 centimeters [cm]), moderate (2.5 to 7.0 cm) and, severe (greater than [>] 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Time frame: Within 7 days after Vaccination 1
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability,were recorded daily using an electronic diary. Fever graded as:1)less than (<)38.0 degrees Celsius [C], 2)greater than or equal to(>=)38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as:mild(increased or prolonged sleeping bouts), moderate(slightly subdued; interfering with daily activity), and severe(disabling; not interested in usual daily activity). Irritability graded as: mild(easily consolable), moderate(required increased attention), and severe(inconsolable; crying could not be comforted). Participants may be represented in >1 row. Here,"Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Time frame: Within 7 days after Vaccination 2
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Time frame: Within 7 days after Vaccination 2
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) < 38.0 degrees C, 2) >= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in >1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Time frame: Within 7 days after Vaccination 3
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Time frame: Within 7 days after Vaccination 3
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) < 38.0 degrees C, 2) >= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in >1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Time frame: Within 7 days after Vaccination 4
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched [with crying]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Time frame: Within 7 days after Vaccination 4
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) < 38.0 degrees C, 2) >= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) >40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in >1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3
Time frame: From Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months)
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4
Time frame: From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month)
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4
Time frame: From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months)
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4
Time frame: From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months)
A newly diagnosed chronic medical condition was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

8 secondary outcomes

Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Time frame: 1 month after Vaccination 3
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Time frame: 1 month after Vaccination 4
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Time frame: 1 month after Vaccination 3
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Time frame: 1 month after Vaccination 4
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Time frame: 1 month after Vaccination 3
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Time frame: 1 month after Vaccination 4
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Time frame: 1 month after Vaccination 3
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Time frame: 1 month after Vaccination 4

Results and safety

Results posted to the registry on 30 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC: Multi-dose Vial (With Preservative)	151	139
13vPnC: Single-dose Prefilled Syringe (Without Preservative)	150	139

Primary outcome: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1

Time frame: Within 7 days after Vaccination 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC: Multi-dose Vial (With Preservative) n = 147	13vPnC: Single-dose Prefilled Syringe (Without Preservative) n = 148
Redness: Any	19.7 (13.6 to 27.1)	16.9 (11.2 to 23.9)
Redness: Mild	17.7 (11.9 to 24.8)	12.8 (7.9 to 19.3)
Redness: Moderate	2.0 (0.4 to 5.8)	4.1 (1.5 to 8.6)
Redness: Severe	0 (0.0 to 2.5)	0 (0.0 to 2.5)
Swelling: Any	27.9 (20.8 to 35.9)	33.8 (26.2 to 42.0)
Swelling: Mild	21.8 (15.4 to 29.3)	23.6 (17.1 to 31.3)
Swelling: Moderate	6.1 (2.8 to 11.3)	10.1 (5.8 to 16.2)
Swelling: Severe	0 (0.0 to 2.5)	0 (0.0 to 2.5)

Population analysed: Safety population of infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants analyzed" signifies participants who were evaluable for this outcome measure.

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1

Time frame: Within 7 days after Vaccination 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC: Multi-dose Vial (With Preservative) n = 147	13vPnC: Single-dose Prefilled Syringe (Without Preservative) n = 148
Fever: <38.0 degree C	15.0 (9.6 to 21.8)	10.8 (6.3 to 17.0)
Fever: >=38.0 degree C to 38.4 degree C	10.9 (6.4 to 17.1)	8.1 (4.3 to 13.7)
Fever: 38.5 degree C to 38.9 degree C	1.4 (0.2 to 4.8)	2.7 (0.7 to 6.8)
Fever: 39.0 degree C to 40.0 degree C	1.4 (0.2 to 4.8)	0 (0.0 to 2.5)
Fever: >40.0 degree C	1.4 (0.2 to 4.8)	0 (0.0 to 2.5)
Decreased appetite: Any	42.2 (34.1 to 50.6)	53.4 (45.0 to 61.6)
Decreased appetite: Mild	23.8 (17.2 to 31.5)	30.4 (23.1 to 38.5)
Decreased appetite: Moderate	17.7 (11.9 to 24.8)	21.6 (15.3 to 29.1)

Population analysed: Safety population for infant series included all participants who received at least 1 dose of study vaccine during infant series. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Primary outcome: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2

Time frame: Within 7 days after Vaccination 2. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC: Multi-dose Vial (With Preservative) n = 141	13vPnC: Single-dose Prefilled Syringe (Without Preservative) n = 140
Redness: Any	17.0 (11.2 to 24.3)	19.3 (13.1 to 26.8)
Redness: Mild	16.3 (10.6 to 23.5)	17.9 (11.9 to 25.2)
Redness: Moderate	0.7 (0.0 to 3.9)	1.4 (0.2 to 5.1)
Redness: Severe	0 (0.0 to 2.6)	0 (0.0 to 2.6)
Swelling: Any	24.8 (17.9 to 32.8)	27.9 (20.6 to 36.1)
Swelling: Mild	21.3 (14.8 to 29.0)	22.9 (16.2 to 30.7)
Swelling: Moderate	3.5 (1.2 to 8.1)	5.0 (2.0 to 10.0)
Swelling: Severe	0 (0.0 to 2.6)	0 (0.0 to 2.6)

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2

Time frame: Within 7 days after Vaccination 2. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC: Multi-dose Vial (With Preservative) n = 141	13vPnC: Single-dose Prefilled Syringe (Without Preservative) n = 140
Fever: <38.0 degree C	8.5 (4.5 to 14.4)	8.6 (4.5 to 14.5)
Fever: >=38.0 degree C to 38.4 degree C	6.4 (3.0 to 11.8)	5.7 (2.5 to 10.9)
Fever: 38.5 degree C to 38.9 degree C	2.1 (0.4 to 6.1)	2.1 (0.4 to 6.1)
Fever: 39.0 degree C to 40.0 degree C	0 (0.0 to 2.6)	0 (0.0 to 2.6)
Fever: >40.0 degree C	0 (0.0 to 2.6)	0.7 (0.0 to 3.9)
Decreased appetite: Any	40.4 (32.3 to 49.0)	38.6 (30.5 to 47.2)
Decreased appetite: Mild	27.0 (19.8 to 35.1)	25.0 (18.1 to 33.0)
Decreased appetite: Moderate	12.1 (7.2 to 18.6)	12.1 (7.2 to 18.7)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Infant series: SAEs and non-SAEs= from Vaccination 1 up to 1 month post Vaccination 3 (for 3 months). Between infant series and toddler dose: SAEs:1 month post Vaccination 3 up to pre-vaccination 4 (for 7.5 months), non-SAEs were not planned to be collected. Toddler dose: SAEs and non-SAEs = up to 1 month post Vaccination 4 (for 1 month). Local reactions and systemic events =7 days post any vaccination (systematic assessment). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC, MDV With Preservative: Infant Series	5 of 150 (3.3%)	145 of 150 (96.7%)	0 of 150
13vPnC, PFS Without Preservative: Infant Series	4 of 150 (2.7%)	141 of 150 (94%)	0 of 150
13vPnC, MDV: Between Infant Series and Toddler Dose	6 of 150 (4%)	0 of 0	0 of 150
13vPnC, PFS: Between Infant Series and Toddler Dose	3 of 150 (2%)	0 of 0	0 of 150
13vPnC, MDV With Preservative: Toddler Dose	1 of 139 (0.7%)	58 of 139 (41.7%)	0 of 139
13vPnC, PFS Without Preservative: Toddler Dose	0 of 139 (0%)	54 of 139 (38.8%)	0 of 139

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34656378Lalwani SK, Ramanan PV, Sapru A, Sundaram B, Shah BH, Kaul D, Karthik Nagesh N, Kalina WV, Chand R, Ding M, Suroju S, Scott DA, Lockhart SP. Safety and immunogenicity of a multidose vial formulation of 13-valent pneumococcal conjugate vaccine administered with routine pediatric vaccines in healthy infants in India: A phase 4, randomized, open-label study. Vaccine. 2021 Nov 5;39(46):6787-6795. doi: 10.1016/j.vaccine.2021.09.029. Epub 2021 Oct 14.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 13vPnC in people with Vaccines, run by Pfizer at 7 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (time frame: Within 7 days after Vaccination 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03548337, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.