A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

Hepatitis B Clinical Trial

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™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177722
• Other study ID #: A3L24
• Secondary ID: UTN: U1111-1111-
• Status: Completed
• Phase: Phase 3
• First received: August 6, 2010
• Last updated: April 3, 2014
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCosta Rica: Ministry of Health Costa Rica
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1375
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Days to 65 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Hepatitis B
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
• DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
• DTaP-IPV-Hep B-PRP-T Vaccine
0.5 mL, Intramuscular
• DTaP-Hep B-IPV vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Colombia,  Costa Rica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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™	Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.	Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination	No
Primary	Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	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).	30 Days post-dose 3	No
Secondary	Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine	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).	Day 0 (pre-vaccination) and 30 days post-dose 3	No
Secondary	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	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.	Day 0 up to 7 after each dose	No
Secondary	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	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.	Day 0 up to 7 post each vaccination	No

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