Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

Hepatitis B Clinical Trial

Official title:

Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313911
• Other study ID #: A3L04
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2006
• Last updated: April 2, 2014
• Start date: July 2006
• Est. completion date: February 2008

Study information

• Verified date: April 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: General Directorate of Pharmaceuticals, Devices, and DrugsMexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject.

To evaluate the overall safety in terms of:

Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.

Immunogenicity:

To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP~T vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2133
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Days to 71 Days

Eligibility

Inclusion Criteria:

• 2 months old infants 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 and 1 or 2 independent witnesses

• Able to attend all scheduled visits and to comply with all trial procedures

• Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.

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

• Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy

• Subjects with congenital or acquired immunodeficiency in the child's surrounding

• 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

• Blood or blood-derived products received since birth

• Any vaccination in the 4 weeks preceding the first trial vaccination

• Vaccination planned in the 4 weeks following the trial vaccination

• Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)

• Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen

• Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s)

• Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination

• History of seizures

• Febrile or acute illness on the day of inclusion.

Study Design

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

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b
• Hepatitis B
• Pertussis
• Tetanus

Intervention

Biological:
• DTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular (IM)
• Tritanrix-HepB/Hib
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

Mexico,  Peru, 

References & Publications (1)

Macías M, Lanata CF, Zambrano B, Gil AI, Amemiya I, Mispireta M, Ecker L, Santos-Lima E. Safety and immunogenicity of an investigational fully liquid hexavalent DTaP-IPV-Hep B-PRP-T vaccine at two, four and six months of age compared with licensed vaccine — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.	High fever was defined as rectal temperature equivalent to = 39.6ºC.	Day 0 up to Day 7 post-injection	No
Secondary	Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo	Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.	Day 30 post-dose 3	No
Secondary	Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo	Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.; Two Seroprotection thresholds were defined: a titer = 10 mIU/mL and = 100 mIU/mL, respectively.	Day 30 post-dose 3	No
Secondary	Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination	Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.; Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, =5 cm; Fever =39.6 ºC; Vomiting, =6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses =3 feeds or refuses most feeds; Irritability, inconsolable.	Day 0 up to Day 7 Post-injection	No

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