Alum Phospate Adjuvated QuimiHib® Vaccine Clinical Study.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

“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.”

Secondary indentifying numbers:

IG/VHI/HIB/0107

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

HeberBiotec S.A.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

16/07/2007

Reference number:

05.008.07.B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Sergio González Fiallo, MD

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Matanzas, “Moncada” Polyclinics, Amado Hernández Valdés, MD. Matanzas, “Manuel Fajardo” Polyclinics, Nelson Clemente Díaz Arregoitía, MD. Matanzas, “Camarioca” Polyclinics, Lázaro Francisco Hernández Lima, MD. Matanzas, “José Antonio Echeverría” Polyclinics, Juan Manuel González Martin, MD.

Research ethics committees:

Regional Scientific Ethic Committee, (created in Cardenas municipality, Matanzas Province), May 04, 2007

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

15/02/2008

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Haemophilus influenzae type b infection prophylaxis.

Intervention(s):

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

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

15 months

Maximum age:

18 months

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:

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.

Type of population:

Children

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

178

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Dr. Arístides

Last Name:

Aguilar Betancourt

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2716022

Email :

aristides.aguilar@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Dr. Arístides

Last Name:

Aguilar Betancourt

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2716022

Email :

aristides.aguilar@cigb.edu.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000101

Date of Registration in Primary Registry:

2011-04-28

Record Verification Date:

2011-04-18 20:00

Link to the spanish version:

Click here [3]