Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00401531
First received: November 16, 2006
Last updated: September 30, 2011
Last verified: September 2011
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Purpose
The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth.
Primary Objective:
To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar®
Secondary Objectives:
Immunogenicity:
To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series.
Safety:
To describe the overall safety after each injection.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B Polio Diphtheria Pertussis Haemophilus Influenzae Type b |
Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Immunogenicity Study of a DTaP IPV Hep B PRP T Combined Vaccine in Comparison to Infanrix Hexa™, Both Concomitantly Administered With Prevnar™ at 2, 4, and 6 Months of Age in Thai Infants |
Resource links provided by NLM:
MedlinePlus related topics:
Diphtheria
Flu
Hepatitis
Hepatitis A
Hepatitis B
Polio and Post-Polio Syndrome
Whooping Cough
Drug Information available for:
Boostrix
Heptavalent pneumococcal conjugate vaccine
Adacel
Pneumococcal Vaccines
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the immune response to DTaP-IPV-HB-PRP~T vaccine after concommitant vaccination with Prevnar® [ Time Frame: 1 Month post-dose 3 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To provide information concerning the immune response to the components of DTaP-IPV-HB-PRP~T and Infanrix™-Hexa vaccines [ Time Frame: 1 Month post-dose 3 ] [ Designated as safety issue: No ]
| Enrollment: | 412 |
| Study Start Date: | October 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1: DTaP IPV Hep B PRP T + Prevnar™ |
Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines
0.5 mL, IM
Other Name: Prevnar®
|
| Active Comparator: Group 2: Infanrix hexa™ + Prevnar™ |
Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
0.5 mL, IM
Other Names:
|
Eligibility| Ages Eligible for Study: | 50 Days to 71 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria :
- Two month old infant (50 to 71 days old) on the day of inclusion, of either gender.
- Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kg.
- Hepatitis B vaccination since birth.
- Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria :
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Blood or blood-derived products received since birth.
- Any vaccination in the 4 weeks preceding the first trial vaccination.
- Any planned vaccination (except trial vaccinations) during the trial.
- Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically).
- Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae.
- Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity.
- Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- History of seizures.
- Febrile (rectal equivalent temperature >= 38.0°C) or acute illness on the day of inclusion.
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00401531 History of Changes |
| Other Study ID Numbers: | A3L12 |
| Study First Received: | November 16, 2006 |
| Last Updated: | September 30, 2011 |
| Health Authority: | Thailand: Food and Drug Administration |
Keywords provided by Sanofi:
|
Hepatitis B Polio Diphtheria Pertussis H. influenzae type b |
Additional relevant MeSH terms:
|
Diphtheria Hepatitis Hepatitis A Hepatitis B Influenza, Human Whooping Cough Poliomyelitis Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Orthomyxoviridae Infections Respiratory Tract Infections Respiratory Tract Diseases Bordetella Infections Gram-Negative Bacterial Infections Infection Myelitis Central Nervous System Viral Diseases Central Nervous System Infections Central Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013