Reactogenicity and Immunogenicity of the pentavalent vaccine DPT-HB+Hib. Schedule 6-10-14 weeks.

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000100
• Date of registration: 27/04/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB).
• Public title: Reactogenicity and Immunogenicity of the pentavalent vaccine DPT-HB+Hib. Schedule 6-10-14 weeks.
• Scientific title: Evaluation of the safety and immunogenicity of combined pentavalent vaccine DPT-HB-Hib, liquid, in healthy suckling children according to a schedule of administration at 6-10-14 weeks of age. Open and randomized clinical trial.
• Date of first enrolment: 10/11/2009
• Target sample size: 149
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000100-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Parallel Purpose: Prevention

Countries of recruitment

Cuba

Contacts

• Name: Pablo Díaz Reyes
• Affiliation: Center for Genetic Engineering and Biotechnology.

• Name: Pablo Díaz Reyes
• Affiliation: Center for Genetic Engineering and Biotechnology.

Key inclusion & exclusion criteria

Inclusion criteria: Newborns on term of any sex, healthy, with normal history and clinical exam. Participating in a voluntary way (signing of the Informed Consent by the parents). Nutritional evaluation over the tenth percent (p10), so when born (weigh > 2500 gr ) as when to the suckling child before each dose. Children from mothers with absence of surface antigen against the virus of hepatitis B during pregnancy. Not having received vaccines against Tetanus, Diphtheria, Whooping Cough or Haemophilus influenzae previously to the initiation of the study or beyond the study, once initiated this.
Exclusion criteria: Absence of any of the inclusion criteria. Temperature = 37 °C in the moment of the visit for administering the vaccine or within the 24 previous hours having a diagnose of acute infectious disease at the moment of the application of the vaccine or in the three previous days. Presenting, when born, a diagnosis of any of the following conditions: congenital irregularity, endocrine-metabolic disease, convulsive encephalopathy, chronic disease involving the liver or the hemolymphopoietic, respiratory, or urogenital systems, etc. If the family plans to change home or move out of the locality during the period of duration of the study. Icteric disease of any origin (except physiological icterus) or acute hepatic disease. Background of having received any vaccine against Hepatitis B, DPT or Haemophilus influenzae that is not within those administered in the study. Allergy to any of the components of the vaccine (for instance, Tiomersal). The administration during the assay of any medicament immuno-stimulating or immuno-modulator (cortico-esteroids for more than two weeks, immunoglobulin, etc).

Age minimum: Infants (5.3 weeks)
Age maximum: Infants (6.6 weeks)
Gender: Both

Health Condition(s) or Problem(s) studied

Prophylaxis against infections diseases: Diphtheria, Tetanus, B. pertussis, H. influenzae type b and hepatitis B.

Intervention(s)

Group I (study): Received the combined DPT-HB-Hib vaccine (liquid), 0.5 mL. Group II (control): Received the commercial combined DPT-HB+Hib vaccine (Heberpenta), 0.74 mL. Both groups received the vaccine by intramuscular route, with a schedule of 6-10-14 week.

Primary Outcome(s)

Safety: Measuring time: 1 hour, 24, 48 and 72 hours and 7 and 30 days after each dose. Measured as: Local Events (Erythema, Induration, Pain, Infiltration, abscess) and Sistemic Events (Fever, feverish, irritability, vomits, persistent crying, anaphylactic shock).

Secondary Outcome(s)

Immunogenicity: Measuring time: 30 days after the 3rd dose (last dose). Measured as: Anti-HBsAg titres = 10 IU/L, and % of hyper-response (anti-HBsAg titres = 100 IU/L). Titres against the diphtheria and tetanic toxoids = 0.1 IU/mL, Titres anti-B. pertussis specific = 11 UN (Novatec Units) to the value of cut of the determination. Titres anti-PRP of Hib = 0.15 µg/mL and = 1.0 µg/mL long term protection.

Secondary ID(s)

IG/VHI/DPT-HB-Hib/0701

Source(s) of Monetary Support

Heber Biotec S.A.

Secondary Sponsor(s)

Ministry of Public Health, CUBA.