Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines
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ClinicalTrials.gov Identifier: NCT00254917 |
Recruitment Status :
Completed
First Posted : November 17, 2005
Last Update Posted : April 16, 2012
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The present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age schedule followed by a booster vaccination during the second year of life with the aim to cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccines.
WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks of age) will be also assessed in infants born to HBsAg seronegative mothers.
To assess the safety of Pentaxim.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Tetanus Polio Pertussis Haemophilus Influenzae Type B | Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine | Phase 4 |
Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one of the two study groups as follows:
Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 14 weeks of age, and the recombinant 10 µg hepatitis B vaccine at 0, 6 and 14 weeks of age.
Group B: 212 subjects will receive the PENTAXIM™ and the recombinant 10 µg hepatitis B vaccines at 6, 10 and 14 weeks of age.
All infants included in the study will receive a booster dose of PENTAXIM™ vaccine at 18-19 months of age.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 387 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | February 2006 |
Actual Study Completion Date : | February 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Concommitant recombinant hepatitis B vaccine at 0, 6 and 14 weeks of age
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Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
0.5 mL, IM
Other Name: PENTAXIM™ |
Experimental: 2
Concommitant recombinant hepatitis B vaccine at 6, 10, and 14 weeks of age.
|
Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
0.5 mL, IM
Other Name: PENTAXIM™ |
- To provide information concerning the safety of PENTAXIM™ Vaccine. [ Time Frame: 20 months ]

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Ages Eligible for Study: | 6 Weeks to 19 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention
- Healthy male or female newborn
- Age ranging from birth to 48 hours of life (included)
- Birth weight >2.5 kg and gestational age >37 weeks
- Born to HBs antigen-negative mother
Exclusion Criteria:
- Known previous therapy of the mother with cadaveric pituitary derived human growth hormone
- Infant presently enrolled or scheduled to be enrolled in another clinical trial
- Infant with moderate or severe illness, mainly infectious diseases
- Infant with fever (rectal temperature > 38°C or axillary temperature > 37.5°C)
- Infant with severe congenital defects or abnormalities
- Uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Known immunological deficiency (including a known HIV seropositive mother)
- Administration of vaccine since birth (other than BCG)
- Previous or planned administration of immunosuppressive therapy, immunoglobulins and /or any blood-derived products (inhaled and topical corticoids are allowed)

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): NCT00254917
Philippines | |
Manila, Philippines |
Study Director: | Clinical Trials | Sanofi Pasteur, a Sanofi Company |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00254917 |
Other Study ID Numbers: |
E2I29 |
First Posted: | November 17, 2005 Key Record Dates |
Last Update Posted: | April 16, 2012 |
Last Verified: | April 2012 |
Pentaxim |
Diphtheria Bacterial Infections Bacterial Infections and Mycoses Infections Gram-Positive Bacterial Infections |
Corynebacterium Infections Actinomycetales Infections Vaccines Immunologic Factors Physiological Effects of Drugs |