Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
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ClinicalTrials.gov Identifier: NCT00654901 |
Recruitment Status :
Completed
First Posted : April 9, 2008
Results First Posted : June 26, 2013
Last Update Posted : May 13, 2016
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This is a follow-up of Study A3L11 (NCT00404651).
Immunogenicity
- To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.
- To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of subjects.
Safety
- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.
Condition or disease | Intervention/treatment | Phase |
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Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Haemophilus Influenzae Type B Infection | Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1) Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 2) Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 3) Biological: Infanrix Hexa™ | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 881 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Immunogenicity Study of the Antibody Persistence and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
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Experimental: DTaP-IPV-Hep B-PRP~T Batch 1
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651); and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
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Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
0.5 mL, Intramuscular |
Experimental: DTaP-IPV-Hep B-PRP~T Batch 2
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
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Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
0.5 mL, Intramuscular |
Experimental: DTaP-IPV-Hep B-PRP~T Batch 3
Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
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Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
0.5 mL, Intramuscular |
Active Comparator: Infanrix Hexa™
Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix Hexa™) plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 (NCT00404651) and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
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Biological: Infanrix Hexa™
0.5 mL, Intramuscular |
- Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T [ Time Frame: Day 0 (pre-booster) and Day 30 (one month post-booster) ]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 by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). 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 ELISA.
- Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine [ Time Frame: Day 0 (pre-booster) and Day 30 (one month post-booster) ]
Antibody persistence and immunogenicity response:
Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.
- Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine [ Time Frame: Days 0 up to 7 after any injection ]
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.
Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.

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Ages Eligible for Study: | 15 Months to 18 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age
- Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
- Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
- Participation in another clinical trial in the 4 weeks preceding the booster vaccination.
- Planned participation in another clinical trial during the present trial period.
- 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 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 in the last 3 months.
- Any vaccination in the 4 weeks preceding the booster vaccination.
- Any vaccination planned until the next visit.
- History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or microbiologically).
- Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or hepatitis B infection(s) since the end of participation in Study A3L11.
- Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
- Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or Hepatitis C seropositivity.
- Subjects with any related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11.
- History of seizures.
- Febrile (temperature ≥38.0°C) or acute illness on the day of inclusion
- Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; Temperature >40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for >3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.

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): NCT00654901
Mexico | |
Estado de Mexico, Mexico | |
Insurgentes Cuicuilco, Mexico | |
Monterrey, Mexico | |
Puebla, Mexico |
Study Director: | Medical Director | Sanofi Pasteur, a Sanofi Company |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00654901 |
Other Study ID Numbers: |
A3L21 |
First Posted: | April 9, 2008 Key Record Dates |
Results First Posted: | June 26, 2013 |
Last Update Posted: | May 13, 2016 |
Last Verified: | April 2016 |
Diphtheria Tetanus Pertussis Hepatitis B |
Poliomyelitis Invasive Haemophilus influenzae type b. Haemophilus Influenzae Type B Infection |
Influenza, Human Hepatitis B Whooping Cough Tetanus Diphtheria Poliomyelitis Haemophilus Infections Hepatitis Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Respiratory Tract Infections Orthomyxoviridae 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 Nervous System Diseases |