Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00404651
First received: November 28, 2006
Last updated: January 11, 2010
Last verified: January 2010
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Purpose
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.
The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.
The secondary objectives are:
- To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
- To assess the overall safety in each group one month after the third dose of the primary series.
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis |
Biological: DTaP-IPV-HB-PRP~T vaccine Biological: DTaP-IPV-HB-PRP~T vaccine Biological: DTaP-HBV-IPV vaccine |
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: | Lot to Lot Consistency Study of DTaP IPV Hep B PRP T Vaccine Administered at 2 4 6 Months of Age in Healthy Mexican Infants |
Resource links provided by NLM:
MedlinePlus related topics:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Polio and Post-Polio Syndrome
Tetanus
Whooping Cough
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the immunogenicity of DTaP-IPV-HB-PRP~T after vaccination. [ Time Frame: 1 Month post-dose 3 ] [ Designated as safety issue: No ]
| Enrollment: | 1189 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Participants receive vaccine Batch A
|
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
|
|
Experimental: Group 2
Participants receive vaccine Batch B
|
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
|
|
Experimental: Group 3
Participants receive vaccine Batch C
|
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
|
|
Active Comparator: Group 4
Participants receive Infanrix hexa™
|
Biological: DTaP-HBV-IPV vaccine
0.5 mL, IM
Other Name: INFANRIX®HEXA
|
Eligibility| Ages Eligible for Study: | 2 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria :
- Two months old infants on the day of inclusion
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by one or both parents or by the guardian and two independent witnesses
- Able to attend all scheduled visits and to comply with all trial procedures
- Received BCG vaccine between birth and one month of life in agreement with the national immunization calendar.
Exclusion Criteria :
- Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency
- 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
- 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 four weeks preceding the first trial visit
- Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
- Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
- Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
- Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular 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:
No publications provided
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc |
| ClinicalTrials.gov Identifier: | NCT00404651 History of Changes |
| Other Study ID Numbers: | A3L11 |
| Study First Received: | November 28, 2006 |
| Last Updated: | January 11, 2010 |
| Health Authority: | Mexico: Ministry of Health |
Keywords provided by Sanofi:
|
Diphtheria Tetanus Pertussis |
Hepatitis B Poliomyelitis Invasive Haemophilus influenzae type b. |
Additional relevant MeSH terms:
|
Diphtheria Hepatitis Hepatitis A Hepatitis B Whooping Cough Poliomyelitis Tetanus Tetany 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 Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Myelitis Central Nervous System Viral Diseases Central Nervous System Infections Central Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013