Phase 3
Completed N=458
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
Source: ClinicalTrials.gov NCT00303316 ↗Enrolled (actual)
458
Serious AEs
0.9%
Results posted
Feb 2013
Primary outcomePrimary: Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. — 195; 221; 171; 164 Participants
Summary
This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series.
Primary Objective:
To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity.
Secondary objective:
To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. |
195; 221; 171; 164; 169; 165 | — |
| PRIMARY Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. |
220; 215; 216; 214; 222; 219 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. |
87.6; 197; 0.399; 0.326; 27.4; 41.4 | — |
| SECONDARY Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ |
112; 117; 8; 12; 66; 93 | — |
Eligibility Criteria
Inclusion Criteria
- Toddler at 18 months of age (range: 510 days to 578 days of age inclusive)
- Participated in study A3L02 (NCT00831311) and has completed the three-dose primary series with either diphtheria, tetanus, pertussis (2-component acellular), recombinant Hepatitis B Hansenula and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T) or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age
- Written informed consent form signed by at least one parent or by a legal representative and an independent witness
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
- Participation in another clinical trial in the four weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received in the last six months
- Any vaccination in the four weeks preceding the trial
- Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B antigen, since the end of the primary series
- History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B infection(s) (confirmed either clinically, serologically, or microbiologically)
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- History of seizures
- Fever (axillary temperature ≥37.4°C or equivalent rectal temperature ≥38.0°C) or acute illness on the day of inclusion
- Known contraindication to further vaccination with a pertussis vaccine such as:
- Encephalopathy; Inconsolable crying for >3 hours within 48 hours following vaccine injection
- Hypotonic hyporesponsive episode within 48 hours following vaccine injection
- Seizures with or without fever within three days following vaccine injection
- Axillary temperature >39.4°C or equivalent rectal temperature > 40.0°C within 48 hours following vaccine injection.
Data sourced from ClinicalTrials.gov (NCT00303316). 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.