Reactogenicity and Immunogenicity of the pentavalent vaccine DPT-HB+Hib. Schedule 2-4-6 months.

Evaluation of the safety and immunogenicity of the combined pentavalent vaccine DPT-HB-Hib, liquid, in healthy suckling children according to a schedule of administration at 2-4-6 months of age. Comparative, open and randomized clinical trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000103

Enrollment

624

Registered

2011-04-29

Start date

2007-02-13

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 vac

Eligibility

Sex/Gender

All

Inclusion 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 ). 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, Hepatitis B or Haemophilus influenza previously to the initiation of the study or beyond the study, once initiated this.

Exclusion criteria

Exclusion criteria: 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. Allergy to any of the components of the vaccine (for instance, Tiomersal).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Cuba

Contacts

Public ContactPablo Díaz Reyes

Center for Genetic Engineering and Biotechnology.

pablo.dias@cigb.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026