Alum Phospate Adjuvated QuimiHib® Vaccine Clinical Study.

“Reactogenicity and immunogenicity of a new formulation of the cuban conjugated vaccine against Haemophilus influenzae type b (QuimiHib®) adjuvated in aluminium phosphate in healthy infants. A controlled, randomized, doubled blinded clinical trial.”

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000101

Enrollment

178

Registered

2011-04-28

Start date

2008-02-15

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

Haemophilus influenzae type b infection prophylaxis.

Interventions

Study Group QuimiHib vaccine (Hib-AlPO4): A unique dose of 10µg sPRP-T/mL by intramuscular route Control Group QuimiHib-adjuvant free: A unique dose of 10µg sPRP-T/mL by intramuscular route

Eligibility

Sex/Gender

All

Age

15 Months to 18 Months

Inclusion criteria

Inclusion criteria: 1) Voluntary participation (signature of informed consent by parents). 2) Healthy children of both sexes, aged 15-18 months of age, with history and normal clinical examination. 3) Nutritional evaluation over 10 percentile. 4) History of full primary immunization series against Hib (2-4-6 months).

Exclusion criteria

Exclusion criteria: 1) Having received the booster dose against Haemophilus influenzae type b. 2) Submit acute infectious disease at the time of vaccination or within three days prior to the administration of it. 3) Higher temperature at 37oC at the time of the visit to administer the vaccine or from the previous 24 hours. 4) History of chronic diseases eg. Bronchial Asthma, Congenital or acquired Cardiopathies, neuropathies, haematological diseases, etc. 5) Thiomersal allergy or allergy to any components of the vaccine 6) History of convulsive or non-convulsive encephalopathy 7) Underlying immunosuppressive disease, intake of immunosuppressor drugs (including steroids) in the six month period prior to study entry.

Design outcomes

Primary

Measure	Time frame
IgG antiPRP GMT (ug/mL). Measuring time: 30 days after vaccination Short-term (= 0,15 ug/mL) and long-term (= 1ug/mL). Measuring time: 30 days after vaccination Seroprotection percentage (increase 2 or more times in the IgG antiPRP antibody title detected at baseline in pre-booster serum). Measuring time: 30 days after vaccination	—

Secondary

Measure	Time frame
Local and systemic adverse events within 72 hours, and at 7 and 30 days after vaccination.	—

Countries

Cuba

Contacts

Public ContactDr. Arístides Aguilar Betancourt

Center for Genetic Engineering and Biotechnology (CIGB).

aristides.aguilar@cigb.edu.cu

Outcome results

None listed

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