Quimi-Hib® and Quimi-Hib(AlPO4) vaccines in an accelerated 6-10-14 weeks primary vaccination series

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:

“Immunogenicity, tolerance and reactogenicity of Quimi-Hib and alum phospate adjuvanted Quimi-Hib vaccines in healthy infants according to 6 – 10 – 14 weeks primary vaccination series. A multicenter, controlled, randomized, doubled blind clinical trial.”

Secondary indentifying numbers:

IG/QHI/SE/1001

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology

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 :

07/06/2012

Reference number:

05.009.11B

Principal investigator

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

First name:

Dr. Jesús Quintana Hernández, MSc Infectious Diseases, Hygiene & Epidemiology Specialist

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

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, “Contreras” Clinic, Dr. Daymis Reguera Fernández, General Integral Medicine Specialist Matanzas,"Carlos Verdugo” Clinic, Dr. Nurys Ramírez Lovio, General Integral Medicine Specialist Matanzas, “Milanés” Clinic, Dr. Susana Cabrera Hernández, General Integral Medicine Specialist Matanzas, “Playa” Clinic, Dr. Annelise Grau Nuñez, General Integral Medicine Specialist Matanzas, “Versalles” Clinic, Dr. Ileana Medina, General Integral Medicine Specialist

Research ethics committees:

Regional Center for Hygiene, Epidemiology and Microbiology's Centralized Scientific Ethic Committee, Matanzas, 7.02.2011

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

27/10/2012

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):

Group I (Experimental): alum phosphate adjuvanted Quimi-Hib, 10µg, intramuscular route, 6-10-14 weeks schedule Group II (Control): Quimi-Hib, 10µg, intramuscular route, 6-10-14 weeks schedule

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, Short-term (=0,15 mcg/mL) and long-term (=1 mcg/mL) seroprotection percentages, seroconversion rate (increase in =2 folds in baseline IgG antiPRP antibody titer measured at day 30 after administration of the last vaccine dose).

Key secondary outcomes:

Percentage of local and systemic adverse events Evaluation times: 1h, 24h, 48h, 72h, Days 7 and 30 post-vaccination in each dose. -Occurrence of the Adverse Event (AE) -Description of the AE (name of the AE) -Duration of the AE (difference between start date and stop date) -Intensity of the AE (Mild, Moderate, Severe) -Seriousness of the AE (Serious, no serious) -Action taken with study drug (None, Dose reduced, Dose temporarily reduced, Discontinued ) -Outcomes (Recovered, improved, persisting or recovered with sequels) -Causality (1.Very likely, 2.Probable, 3.Possible, 4. Not Probable, 5. Non-related, 6. Not evaluable)

Selection criterias

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

Gender:

Male/Female

Minimum age:

aged 6 weeks

Maximum age:

7 weeks

Inclusion criteria:

1.Signing of the written inform consent Act by parents/legal guardians. 2.6 weeks old healthy infants, both sexes, with normal clinical examination and medical history. 3.Nutritional evaluation over 10 percentile 4.History of no primary immunization series against Hib or DTP. 5.Administration of the scheduled Hepatitis B vaccine dose at birth

Exclusion criteria:

1.Administration of other Investigation Medicinal Product (IMP) different to IMP under study in the 30 days previous to administration of the 1st vaccine dose or its intention of use during the period planned for the clinical trial. 2.Acute infectious illness or body temperature over 37?C at the moment of vaccination visit. 3.History of preterm delivery (birth before 36th weeks of pregnancy). 4.Major congenital defects or serious chronic disease. 5.Infants with history of convulsive or non-convulsive encephalopathy. 6.Chronic medication (defined as more than 21 days of treatment) with immune-suppressor or immuno-modulatory drugs prior to administration of the 1st vaccine dose. 7.History of invasive Hib disease. 8.Any suspected or diagnosed immune-suppression or immunodeficiency (congenital o secondary), including HIV infection, based on the medical history and physical examination. 9.History of allergic reactions or allergic disease with probability to be exacerbated by any component of the vaccine under study (including thiomersal allergy). 10.Gammaglobulin administration or other blood –derived components during the period prior to administration of the 1st vaccine dose or the intention of administration during the planned trial period. 11.Maternal history for HIV or HBV infection, based on the medical records.

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:

208

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

Middle Name:

Aguilar

Last Name:

Betancourt

Affiliation:

Center for Genetic Engineering and Biotechnology

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacan, PO.Box 6162, Havana, Cuba.

City:

Havana

País:

Cuba

Zip Code:

+53

Telephone:

(53-7)-2087442

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. Aristides

Middle Name:

Aguilar

Last Name:

Betancourt

Affiliation:

Center for Genetic Engineering and Biotechnology, CIGB

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, P Box 6162, Havana, Cuba.

City:

Havana

País:

Cuba

Zip Code:

+53

Telephone:

+(53-7)-2087442

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:

RPCEC00000135

Date of Registration in Primary Registry:

2012-09-12

Record Verification Date:

2012-09-03 20:00

Link to the spanish version:

Click here [3]