- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00404651
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Estado de Mexico, Mexico
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Estado de Mexico, Mexico, 56613
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Insurgentes Cuicuilco, Mexico
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Monterrey, Mexico
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Puebla, Mexico
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Tlalpan, Mexico, 14050
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Participants receive vaccine Batch A
|
0.5 mL, intramuscular (IM)
0.5 mL, IM
|
Experimental: Group 2
Participants receive vaccine Batch B
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0.5 mL, intramuscular (IM)
0.5 mL, IM
|
Experimental: Group 3
Participants receive vaccine Batch C
|
0.5 mL, intramuscular (IM)
0.5 mL, IM
|
Active Comparator: Group 4
Participants receive Infanrix hexa™
|
0.5 mL, IM
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Day 150 (one month post-dose 3)
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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.
|
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).
|
Day 150 (one month post-dose 3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Day 150 (one month post-dose 3)
|
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
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Solicited Injection Site Reactions: Pain, Erythema, and Swelling.
Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability
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Day 0 (pre-each vaccination) up to 7 days post-each dose
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Neuromuscular Diseases
- Central Nervous System Infections
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Bordetella Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Clostridium Infections
- Corynebacterium Infections
- Myelitis
- Hepatitis B
- Whooping Cough
- Hepatitis
- Tetanus
- Diphtheria
- Poliomyelitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- A3L11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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