Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
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ClinicalTrials.gov Identifier: NCT00348881 |
Recruitment Status :
Completed
First Posted : July 6, 2006
Results First Posted : October 22, 2013
Last Update Posted : October 22, 2013
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Condition or disease | Intervention/treatment | Phase |
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Diphtheria Tetanus Pertussis Hepatitis B Influenza | Biological: DTaP-HB-PRP~T combined vaccine Biological: Tritanrix-HepB/Hib™ vaccine Biological: Oral poliomyelitis vaccine (OPV) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2133 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
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Experimental: Group 1: DTaP-Hep B-PRP-T + OPV vaccine
Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
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Biological: DTaP-HB-PRP~T combined vaccine
0.5 mL, Intramuscular Biological: Oral poliomyelitis vaccine (OPV) Oral co-administered with study vaccine. |
Active Comparator: Group 2: Tritanrix-HepB/Hib™ + OPV vaccine
Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
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Biological: Tritanrix-HepB/Hib™ vaccine
0.5 mL, Intramuscular Biological: Oral poliomyelitis vaccine (OPV) Oral co-administered with study vaccine. |
- Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: 1 month post third vaccination ]
Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.
Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.
- Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. [ Time Frame: Day 0 to Day 7 post-vaccination ]Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
- Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: 1 month post third vaccination ]Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.
- Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV [ Time Frame: Day 0 to Day 7 after vaccination ]
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.
Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.

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Ages Eligible for Study: | 42 Days to 50 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
At Screening:
- 0 to 3 day old infants
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Apgar score ≥ 7 at three minutes after birth
- Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
At Inclusion:
- Six weeks of age
- Received a dose of Hepatitis B (HB) in the first three days of life
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
At Screening:
- Illness at a stage that could interfere with trial conduct or completion
- Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth)
- Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
- Acute illness on the day of screening.
At Screening and at Inclusion:
- Blood or blood-derived products received since birth
- Planned participation in another clinical trial during the present trial period
- Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
- Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)
At Inclusion:
- Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
- Participation in another clinical trial before the first trial vaccination
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
- 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
- Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
- Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
- History of seizures
- Febrile (rectal 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): NCT00348881
Philippines | |
Alabang, Muntinlupa City, Philippines | |
Putatan,, Muntinlupa City, Philippines | |
Tunasan,, Muntinlupa City, Philippines | |
Filinvest | |
Corporate City, Philippines |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00348881 |
Other Study ID Numbers: |
AL201 |
First Posted: | July 6, 2006 Key Record Dates |
Results First Posted: | October 22, 2013 |
Last Update Posted: | October 22, 2013 |
Last Verified: | August 2013 |
Diphtheria Tetanus Pertussis Hepatitis B Hansenula (HB) Haemophilus influenzae type b |
Hepatitis B Whooping Cough Tetanus Diphtheria Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Respiratory Tract Infections Respiratory Tract Diseases Blood-Borne Infections Communicable Diseases |
Hepadnaviridae Infections DNA Virus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections Vaccines Immunologic Factors Physiological Effects of Drugs |