Phase 2
Completed N=249
Study Evaluating Pneumococcal Vaccine in Healthy Infants
Healthy Subjects · pneumococcal infections
Source: ClinicalTrials.gov NCT00205803 ↗
Enrolled (actual)
249
Serious AEs
3.9%
Results posted
Aug 2012
Primary outcomePrimary: Percentage of Participants Reporting Pre-Specified Local Reactions — 34.5; 43.5; 28.2; 36.4 percentage of participants
Summary
The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions |
34.5; 43.5; 28.2; 36.4; 24.3; 25.6 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events |
16.7; 16.5; 21.6; 24.6; 20.0; 20.4 | — |
| PRIMARY Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series |
96.81; 99.07; 88.30; 88.79; 96.81; 99.07 | — |
| SECONDARY Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose |
97.4; 98.9; 100.0; 100.0; 98.7; 100.0 | — |
| SECONDARY Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series |
1.81; 2.40; 2.74; 2.86; 1.52; 1.78 | — |
| SECONDARY Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose |
0.33; 0.48; 2.86; 4.09; 0.84; 0.95 | — |
| SECONDARY Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series |
89.29; 86.21; 70.24; 63.22; 100.00; 100.00 | — |
| SECONDARY Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series |
1.99; 1.64 | — |
| SECONDARY Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series |
1257.74; 1300.01 | — |
| SECONDARY Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series |
0.86; 1.04; 0.93; 0.97 | — |
| SECONDARY Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series |
483.72; 479.79; 368.26; 403.45; 914.01; 812.75 | — |
| SECONDARY Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series |
207.85; 225.12; 98.68; 96.58; 141.23; 135.51 | — |
| SECONDARY Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series |
96.67; 100.00; 92.59; 93.33; 100.00; 100.00 | — |
| SECONDARY Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose |
100.00; 90.0; 100.00; 51.4 | — |
| SECONDARY Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose |
2147.58; 599.90; 802.24; 36.62 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,
- In good health as determined by medical history, physical examination and judgment of the investigator,
- Subject must have been born ≥36 weeks of gestational age,
- Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,
- Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation.
Exclusion Criteria
- Previous vaccination with licensed or investigational pneumococcal vaccine,
- Previous vaccination with Hib conjugate, DTaP or IPV vaccines,
- Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,
- 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 palsy,
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection,
- History of culture-proven invasive disease caused by S. pneumoniae,
- Previous anaphylactic reaction to any vaccine or vaccine components,
- Major known congenital malformation or serious chronic disorders,
- Participation in another investigational study (however, observation-only trials are permitted),
- Known or suspected immune deficiency/suppression,
- Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and monoclonal antibody; eg, Synagis®).
Data sourced from ClinicalTrials.gov (NCT00205803). 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. Informational only — not medical advice.