Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

ClinicalTrials.gov ID

NCT03550313

Acronym / sponsor ID

C3571002

Conditions

Pneumococcal Infections

Phase

Phase 2

Study type

Interventional

Recruitment status

TerminatedReason stopped: Study vaccinations and blood draws were halted due to adequacy of a smaller dataset and study feasibility issues. It was not based on any safety concerns.

Enrolment

565 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

1 Jun 2018 (actual)

Primary completion

5 Nov 2020 (actual)

Study completion

5 Nov 2020 (actual)

First posted

8 Jun 2018 (actual)

Results

Posted 30 Nov 2021

Clinical summary

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

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

3

Who may qualify

Ages

42 to 98 days

Sex

All

Healthy volunteers

Accepted

Age groups

Child

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

Interventions

Primary outcome

1. Percentage of Participants With Local Reactions Within 7 Days After Dose 1

   Time frame: Within 7 Days After Dose 1

   Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

2. Percentage of Participants With Local Reactions Within 7 Days After Dose 2

   Time frame: Within 7 Days After Dose 2

   Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

3. Percentage of Participants With Local Reactions Within 7 Days After Dose 3

   Time frame: Within 7 Days After Dose 3

   Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

4. Percentage of Participants With Local Reactions Within 7 Days After Dose 4

   Time frame: Within 7 Days After Dose 4

   Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

5. Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD)

   Time frame: Within 7 Days After Supplemental Dose

   Local reactions were recorded using an electronic diary by participant's LAR. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

6. Percentage of Participants With Systemic Events Within 7 Days After Dose 1

   Time frame: Within 7 Days After Dose 1

   Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of greater than or equal to (>=) 38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered 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).

7. Percentage of Participants With Systemic Events Within 7 Days After Dose 2

   Time frame: Within 7 Days After Dose 2

   Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered 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).

8. Percentage of Participants With Systemic Events Within 7 Days After Dose 3

   Time frame: Within 7 Days After Dose 3

   Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered 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).

9. Percentage of Participants With Systemic Events Within 7 Days After Dose 4

   Time frame: Within 7 Days After Dose 4

   Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered 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).

10. Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose

    Time frame: Within 7 Days After Supplemental Dose

    Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered 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).

11. Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3

    Time frame: From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months)

    An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

12. Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4

    Time frame: From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month)

    An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

13. Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose

    Time frame: From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month)

    An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

14. Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study

    Time frame: From Dose 1 to End of the Study (up to duration of 17 months)

    An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that was considered to be an important medical event.

15. Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study

    Time frame: From Dose 1 to End of the Study (up to duration of 17 months)

    An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long lasting in its effects.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 37927075Simon MW, Bataille R, Caldwell NS, Gessner BD, Jodar L, Lamberth E, Peng Y, Scott DA, Lei L, Giardina PC, Gruber WC, Jansen KU, Thompson A, Watson W. Safety and immunogenicity of a multivalent pneumococcal conjugate vaccine given with 13-valent pneumococcal conjugate vaccine in healthy infants: A phase 2 randomized trial. Hum Vaccin Immunother. 2023 Aug;19(2):2245727. doi: 10.1080/21645515.2023.2245727. Epub 2023 Nov 5.
• 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.

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