Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
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ClinicalTrials.gov Identifier: NCT00404651 |
Recruitment Status :
Completed
First Posted : November 29, 2006
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis | Biological: DTaP-IPV-HB-PRP~T vaccine Biological: DTaP-HBV-IPV vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1189 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1
Participants receive vaccine Batch A
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Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, intramuscular (IM) |
Experimental: Group 2
Participants receive vaccine Batch B
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Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM |
Experimental: Group 3
Participants receive vaccine Batch C
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Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM |
Active Comparator: Group 4
Participants receive Infanrix hexa™
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Biological: DTaP-HBV-IPV vaccine
0.5 mL, IM
Other Name: INFANRIX®HEXA |
- Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine [ Time Frame: Day 150 (one month post-dose 3) ]Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
- Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. [ Time Frame: Day 150 (one month post-dose 3) ]Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.
- Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine [ Time Frame: Day 150 (one month post-dose 3) ]Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).
- Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine [ Time Frame: Day 150 (one month post-dose 3) ]Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).
- Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine [ Time Frame: Day 0 (pre-each vaccination) up to 7 days post-each dose ]Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability

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Ages Eligible for Study: | 2 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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 Bacillus Calmette Guerin (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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404651
Mexico | |
Estado de Mexico, Mexico, 56613 | |
Estado de Mexico, Mexico | |
Insurgentes Cuicuilco, Mexico | |
Monterrey, Mexico | |
Puebla, Mexico | |
Tlalpan, Mexico, 14050 |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00404651 |
Other Study ID Numbers: |
A3L11 |
First Posted: | November 29, 2006 Key Record Dates |
Results First Posted: | May 9, 2014 |
Last Update Posted: | May 9, 2014 |
Last Verified: | April 2014 |
Diphtheria Tetanus Pertussis |
Hepatitis B Poliomyelitis Invasive Haemophilus influenzae type b. |
Hepatitis B Whooping Cough Tetanus Diphtheria Poliomyelitis Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections |
Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Respiratory Tract Infections Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Nervous System Diseases Corynebacterium Infections Actinomycetales Infections Myelitis |