Pneumococcal VaccinesPhase 3NCT01964716

13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Vaccines, run by Pfizer at 2 sites in The Gambia.

Completed

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

Official record

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Trial summary

This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation. Read more about this study

Who is it for?: Ages 42 to 70 daysHealthy volunteers can take part
Conditions the study is for: Pneumococcal Vaccines
What is being tested?: 13-valent pneumococcal conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 2 sitesThe Gambia
Study dates: Jan 2014to Sep 2014
Phase: Phase 3
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 70 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 42 to 70 days at enrollment.
Determined by medical history, physical examination, and clinical judgment to be eligible for the study
Weight of 3.5 kg or greater at the time of enrollment

Who cannot join

Previous vaccination with licensed or investigational pneumococcal vaccine.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with pneumococcal conjugate vaccine.
Receipt of blood products or gamma-globulin since birth

Trial locations and contacts

2 sites in 1 country.

The Gambia2 sites

Medical Research Council Unit, The Gambia
Fajara, The Gambia, West Africa, 000273
Fajikunda Major Health Centre
Ksmd, The Gambia

Other trials in The Gambia

About this study

Official title: A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants

It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.

Conditions: Pneumococcal Vaccines
Being tested: 13-valent pneumococcal conjugate vaccine
Keywords: Prevenar 13, 13vPnC, Healthy Subjects

What participants receive

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

13-valent pneumococcal conjugate vaccineBiological
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
13-valent pneumococcal conjugate vaccineBiological
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

Study groups in NCT01964716
Study group	Role	What they receive
Multidose Vial Group	Experimental	Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation. Each dose is 0.5 mL Receives: Biological: 13-valent pneumococcal conjugate vaccine
Single-Dose Syringe Group	Active comparator	Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation. Each dose is 0.5 mL Receives: Biological: 13-valent pneumococcal conjugate vaccine

What is being measured

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

Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Measured: 1 month after the infant series
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Measured: 1 month after the infant series
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Measured: Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Measured: Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Measured: Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
Measured: Dose 1 up to 28 to 42 days after dose 3
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An 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. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm.
Measured: Informed consent up to Dose 1

Secondary outcomes (2)

Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Percentage of participants achieving OPA Titer >= lower limit of quantitation (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) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype.
Measured: 1 month after the infant series
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here "n"= participants evaluable =specified category.
Measured: 1 month after the infant series

Timeline

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

Jan 2014Sep 2014

First posted17 Oct 2013 (estimated)
Study startJan 2014
Primary completionSep 2014
Study completionSep 2014

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 Pneumococcal 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01964716
Sponsor's protocol ID: B4671001
Other IDs: 2012-000482-21
Status last verified: Feb 2015
First submitted: 9 Sep 2013
Last updated: 13 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Idoko OT, Mboizi RB, Okoye M, Laudat F, Ceesay B, Liang JZ, Le Dren-Narayanin N, Jansen KU, Gurtman A, Center KJ, Scott DA, Kampmann B, Roca A. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) formulated with 2-phenoxyethanol in multidose vials given with routine vaccination in healthy infants: An open-label randomized controlled trial. Vaccine. 2017 May 31;35(24):3256-3263. doi: 10.1016/j.vaccine.2017.04.049. Epub 2017 May 4.
PubMed 28479175

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?

See locations

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All Pneumococcal Vaccines trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants
ClinicalTrials.gov ID: NCT01964716
Acronym / sponsor ID: B4671001
Conditions: Pneumococcal Vaccines
Keywords: Prevenar 13, 13vPnC, Healthy Subjects
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 17 Oct 2013 (estimated)
Results: Posted 13 Mar 2015

Clinical summary

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

It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.

Study design

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

Arm	Type	Receives
Multidose Vial Group	Experimental	Biological: 13-valent pneumococcal conjugate vaccineSubjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation. Each dose is 0.5 mL
Single-Dose Syringe Group	Active comparator	Biological: 13-valent pneumococcal conjugate vaccineSubjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation. Each dose is 0.5 mL

Who may qualify

Ages: 42 to 70 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Aged 42 to 70 days at enrollment.
Determined by medical history, physical examination, and clinical judgment to be eligible for the study
Weight of 3.5 kg or greater at the time of enrollment

Key exclusion criteria (4 listed)

Previous vaccination with licensed or investigational pneumococcal vaccine.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with pneumococcal conjugate vaccine.
Receipt of blood products or gamma-globulin since birth

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
13-valent pneumococcal conjugate vaccineSubjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.	Biological	Multidose Vial Group
13-valent pneumococcal conjugate vaccineSubjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.	Biological	Single-Dose Syringe Group

Primary outcome

Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Time frame: 1 month after the infant series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Time frame: 1 month after the infant series
Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Time frame: Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Time frame: Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Time frame: Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Time frame: Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Time frame: Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Time frame: Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
Time frame: Dose 1 up to 28 to 42 days after dose 3
An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
Time frame: Informed consent up to Dose 1
An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An 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. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm.

2 secondary outcomes

Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Time frame: 1 month after the infant series
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Time frame: 1 month after the infant series

Results and safety

Results posted to the registry on 13 Mar 2015, 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 (MDV)	250	245
13vPnC Single-Dose Syringe (SDS)	250	244

Primary outcome: Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group

Time frame: 1 month after the infant series. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC Multi-dose Vial (MDV) n = 245	13vPnC Single-Dose Syringe (SDS) n = 244
Serotype 1 (n=245,244)	99.2 (97.1 to 99.9)	100.0 (98.5 to 100.0)
Serotype 3 (n=245,243)	98.8 (96.5 to 99.7)	99.6 (97.7 to 100.0)
Serotype 4 (n=245,244)	99.6 (97.7 to 100.0)	99.6 (97.7 to 100.0)
Serotype 5 (n=245,244)	95.9 (92.6 to 98.0)	97.1 (94.2 to 98.8)
Serotype 6A (n=243,244)	96.3 (93.1 to 98.3)	97.5 (94.7 to 99.1)
Serotype 6B (n=245,244)	95.1 (91.6 to 97.4)	95.1 (91.6 to 97.4)
Serotype 7F (n=245,244)	99.6 (97.7 to 100.0)	100.0 (98.5 to 100.0)
Serotype 9V (n=245,244)	98.0 (95.3 to 99.3)	98.4 (95.9 to 99.6)

13vPnC Multi-dose Vial (MDV) vs 13vPnC Single-Dose Syringe (SDS): percent difference: -0.8 (97.5% CI -3.4 to 1.2)
13vPnC Multi-dose Vial (MDV) vs 13vPnC Single-Dose Syringe (SDS): percent difference: -0.8 (97.5% CI -3.7 to 1.6)
13vPnC Multi-dose Vial (MDV) vs 13vPnC Single-Dose Syringe (SDS): percent difference: 0.0 (97.5% CI -2.3 to 2.4)

Population analysed: Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.

Primary outcome: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group

Time frame: 1 month after the infant series. Geometric mean (95% Confidence Interval). Unit: microgram per milliliter (mcg/mL)

Measure	13vPnC Multi-dose Vial (MDV) n = 245	13vPnC Single-Dose Syringe (SDS) n = 244
Serotype 1 (n=245,244)	4.59 (4.11 to 5.12)	4.45 (4.01 to 4.93)
Serotype 3 (n=245,243)	1.38 (1.29 to 1.49)	1.74 (1.62 to 1.87)
Serotype 4 (n=245,244)	5.30 (4.84 to 5.81)	5.28 (4.76 to 5.85)
Serotype 5 (n=245,244)	2.00 (1.79 to 2.22)	1.98 (1.79 to 2.20)
Serotype 6A (n=243,244)	2.25 (2.02 to 2.50)	2.19 (1.96 to 2.44)
Serotype 6B (n=245,244)	3.42 (2.91 to 4.02)	3.24 (2.77 to 3.78)
Serotype 7F (n=245,244)	3.92 (3.59 to 4.27)	4.18 (3.83 to 4.55)
Serotype 9V (n=245,244)	2.83 (2.56 to 3.13)	2.75 (2.49 to 3.04)

13vPnC Multi-dose Vial (MDV) vs 13vPnC Single-Dose Syringe (SDS): GMC Ratio: 1.03 (97.5% CI 0.87 to 1.22)
13vPnC Multi-dose Vial (MDV) vs 13vPnC Single-Dose Syringe (SDS): GMC Ratio: 0.79 (97.5% CI 0.71 to 0.90)
13vPnC Multi-dose Vial (MDV) vs 13vPnC Single-Dose Syringe (SDS): GMC Ratio: 1.00 (97.5% CI 0.86 to 1.18)

Primary outcome: Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group

Time frame: Within 5 days after Dose 1(Day 2 to Day 6) of the infant series. Number. Unit: participants

Measure	13vPnC Multi-dose Vial (MDV) n = 248	13vPnC Single-Dose Syringe (SDS) n = 250
Redness: Any	1	0
Redness: Mild	1	0
Redness: Moderate	0	0
Redness: Severe	0	0
Swelling: Any	1	0
Swelling: Mild	1	0
Swelling: Moderate	0	0
Swelling: Severe	0	0

Primary outcome: Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group

Time frame: Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series. Number. Unit: participants

Measure	13vPnC Multi-dose Vial (MDV) n = 248	13vPnC Single-Dose Syringe (SDS) n = 247
Redness: Any (n=247, 247)	2	0
Redness: Mild (n=247, 247)	2	0
Redness: Moderate (n=247, 247)	0	0
Redness: Severe (n=247, 247)	0	0
Swelling: Any (n=247, 247)	2	0
Swelling: Mild (n=247, 247)	2	0
Swelling: Moderate (n=247, 247)	1	0
Swelling: Severe (n=247, 247)	0	0

Population analysed: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days and 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC MDV: Informed Consent to Dose 1	0 of 250 (0%)	2 of 250 (0.8%)	Not reported
13vPnC SDS: Informed Consent to Dose 1	0 of 250 (0%)	0 of 250 (0%)	Not reported
13vPnC MDV: After Dose 1	0 of 250 (0%)	113 of 250 (45.2%)	Not reported
13vPnC SDS: After Dose 1	0 of 250 (0%)	107 of 250 (42.8%)	Not reported
13vPnC MDV: After Dose 2	0 of 249 (0%)	114 of 249 (45.8%)	Not reported
13vPnC SDS: After Dose 2	0 of 248 (0%)	99 of 248 (39.9%)	Not reported
13vPnC MDV: After Dose 3	1 of 247 (0.4%)	97 of 247 (39.3%)	Not reported
13vPnC SDS: After Dose 3	0 of 244 (0%)	102 of 244 (41.8%)	Not reported
Screened Only	0 of 26 (0%)	9 of 26 (34.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28479175Idoko OT, Mboizi RB, Okoye M, Laudat F, Ceesay B, Liang JZ, Le Dren-Narayanin N, Jansen KU, Gurtman A, Center KJ, Scott DA, Kampmann B, Roca A. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) formulated with 2-phenoxyethanol in multidose vials given with routine vaccination in healthy infants: An open-label randomized controlled trial. Vaccine. 2017 May 31;35(24):3256-3263. doi: 10.1016/j.vaccine.2017.04.049. Epub 2017 May 4.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine in people with Pneumococcal Vaccines, run by Pfizer at 2 sites in The Gambia.

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 3 inclusion and 4 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 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in The Gambia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 13 Mar 2015). 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 Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group (time frame: 1 month after the infant series). The study lists 10 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 NCT01964716, 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 13 Mar 2015.