Phase 3
N=500
13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
Pneumococcal Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT01964716 ↗Enrolled (actual)
500
Serious AEs
0.1%
Results posted
Mar 2015
Primary outcome: Primary: 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 — 99.2; 100.0; 98.8; 99.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
99.2; 100.0; 98.8; 99.6; 99.6; 99.6 | — |
| PRIMARY Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group |
4.59; 4.45; 1.38; 1.74; 5.30; 5.28 | — |
| PRIMARY Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group |
1; 0; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group |
2; 0; 2; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group |
9; 7; 9; 7; 0; 0 | — |
| PRIMARY Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group |
7; 7; 7; 7; 1; 0 | — |
| PRIMARY Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group |
3; 8; 3; 7; 0; 1 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series |
123; 127; 1; 0 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1 |
2; 0; 9; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series |
71.7; 79.4; 98.8; 100.0; 100.0; 100.0 | — |
| SECONDARY Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series |
48; 52; 97; 122; 1666; 1492 | — |
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.
It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01964716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.