A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants
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ClinicalTrials.gov Identifier: NCT01177722 |
Recruitment Status :
Completed
First Posted : August 9, 2010
Results First Posted : May 5, 2014
Last Update Posted : May 5, 2014
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The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines.
Primary Objectives:
- To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses.
- To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.
Secondary Objectives:
- To describe in each group the immunogenicity parameters for all antigens for each vaccine
- To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Tetanus Whooping Cough Hepatitis B Poliomyelitis | Biological: DTaP-IPV-Hep B-PRP-T Vaccine Biological: DTaP-Hep B-IPV vaccine | Phase 3 |
Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6 months of age and Rotarix™ at 2 and 4 months of age.
All participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1375 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, 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 Latin American Infants Concomitantly With Prevenar™ and Rotarix™ |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1: DTaP-IPV-Hep B-PRP-T (Lot A) |
Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular |
Experimental: Group 2: DTaP-IPV-Hep B-PRP-T (Lot B) |
Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular |
Experimental: Group 3: DTaP-IPV-Hep B-PRP-T (Lot C) |
Biological: DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular |
Active Comparator: Group 4: Active Control |
Biological: DTaP-Hep B-IPV vaccine
0.5 mL, Intramuscular
Other Name: Infanrix hexa™ |
- Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™ [ Time Frame: Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination ]Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.
- Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine [ Time Frame: 30 Days post-dose 3 ]Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).
- Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine [ Time Frame: Day 0 (pre-vaccination) and 30 days post-dose 3 ]Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).
- Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine [ Time Frame: Day 0 up to 7 after each dose ]Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.
- Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine [ Time Frame: Day 0 up to 7 post each vaccination ]Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.

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Ages Eligible for Study: | 55 Days to 65 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
- Two month old infants (55 to 65 days old) 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 legally acceptable representative as per local requirements.
- Able to attend all scheduled visits and to comply with all trial procedures.
- Received Hepatitis B and Bacille de Calmette-Guérin (BCG) vaccines between birth and one month of life in agreement with the national immunization calendar.
Exclusion Criteria :
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroid therapy.
- Known 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, in the opinion of the Investigator.
- Blood or blood-derived products received since birth that might interfere with the assessment of the immune response.
- Any vaccination before trial vaccination (except Hepatitis B and Bacille de Calmette Guérin given at birth).
- Any planned vaccination until 1 month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines).
- 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 pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infections.
- Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C seropositivity.
- Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intramuscular (IM) vaccination.
- History of seizures or encephalopathy.
- Febrile illness (temperature ≥ 38.0°C), or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment.

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): NCT01177722
Colombia | |
Cali, Colombia | |
Costa Rica | |
San José de Costa Rica, Costa Rica |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT01177722 |
Other Study ID Numbers: |
A3L24 UTN: U1111-1111-5801 ( Other Identifier: WHO ) |
First Posted: | August 9, 2010 Key Record Dates |
Results First Posted: | May 5, 2014 |
Last Update Posted: | May 5, 2014 |
Last Verified: | April 2014 |
Diphtheria Tetanus Whooping cough |
Hepatitis B Poliomyelitis Diphtheria-Tetanus-acellular Pertussis Vaccines |
Hepatitis B Tetanus Diphtheria Poliomyelitis Whooping Cough 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 Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Nervous System Diseases Corynebacterium Infections Actinomycetales Infections Myelitis Central Nervous System Infections Central Nervous System Diseases Spinal Cord Diseases |