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

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:

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.

Secondary indentifying numbers:

IG/VHI/DPT-HB-Hib/0701

Issuing authority of the secondary identifying numbers:

CIGB

Source(s) of monetary or material support:

Heber Biotec 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 :

04/02/2008

Reference number:

194/05.022.07.B

Principal investigator

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

First name:

Dr. Alina Villegas Hernández Lic. Dianelis Vázquez Pérez

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

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:

Sancti Spíritus, Norte Polyclinics, Dra. Yaumara Montiel Gracía. Sancti Spíritus, Sur Polyclinics, Lic. Maydelin H. Inerarity Gómez. Sancti Spíritus, Centro Polyclinics, Lic. Sandra Rodríguez Pérez. Sancti Spíritus, Cabaiguan 1 Polyclinics, Dr. Carlos Abreu Pérez. Sancti Spíritus, Fomento Polyclinics, Lic. Eliecer Chávez. Sancti Spíritus, Taguasco Polyclinics, Dra. Nurys Piña Mens. Sancti Spíritus, Zaza del Medio Polyclinics, Dra. Elizabeth García Hernández. Sancti Spíritus, Meneses Polyclinics, Dra. Clara I. Alonso Gopal. Sancti Spíritus, Yaguajay Polyclinics, Dra. Ana Mayra Sanchez Dávila.

Research ethics committees:

Provincial Center of Hygiene and Epidemiology, Sancti Spíritus, July 9, 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:

10/11/2009

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:

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.

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):

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).

Key secondary outcomes:

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.

Selection criterias

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

Gender:

Male/Female

Minimum age:

Infants (5.3 weeks)

Maximum age:

Infants (6.6 weeks)

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).

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:

Open

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

149

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:

Pablo

Middle Name:

Arsenio

Last Name:

Díaz Reyes

Affiliation:

Center for Genetic Engineering and Biotechnology.

Postal Address:

Ave. 31 e/ 158 y 190

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2716022

Email :

pablo.dias@cigb.edu.cu

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:

Pablo

Middle Name:

Arsenio

Last Name:

Díaz Reyes

Affiliation:

Center for Genetic Engineering and Biotechnology.

Postal Address:

Ave. 31 e/ 158 y 190

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)- 2716022

Email :

pablo.dias@cigb.edu.cu

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:

RPCEC00000100

Date of Registration in Primary Registry:

2011-04-27

Record Verification Date:

2011-04-15 20:00

Link to the spanish version:

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Proceso de Registro

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

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