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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II/III Clinical Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants

Who May Be Eligible (Plain English)

Who May Qualify: - healthy infants from 6 weeks to 8 weeks of age (both inclusive) - body weight ≥ 3.2 kg - born at full term pregnancy (≥ 37 weeks) - signed willing to sign a consent form by parent(s) or legally acceptable representative(s) Who Should NOT Join This Trial: - Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis - Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration - Known history of SARS-CoV-2 infection - Participant's mother is HepB antigen or HIV positive - Fever ≥ 38.0 C/100.4 F within 3 days prior to enrollment - Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG) - Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination - Received immunosuppressive agents or other immune-modifying drugs - Previous use of blood or blood-derived products - Any history of allergy (hypersensitivity) to any of the vaccine components - Participation in another interventional clinical trial within 4 weeks of expected first vaccination Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * healthy infants from 6 weeks to 8 weeks of age (both inclusive) * body weight ≥ 3.2 kg * born at full term pregnancy (≥ 37 weeks) * signed informed consent by parent(s) or legally acceptable representative(s) Exclusion Criteria: * Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis * Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration * Known history of SARS-CoV-2 infection * Participant's mother is HepB antigen or HIV positive * Fever ≥ 38.0 C/100.4 F within 3 days prior to enrollment * Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG) * Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination * Received immunosuppressive agents or other immune-modifying drugs * Previous use of blood or blood-derived products * Any history of allergy (hypersensitivity) to any of the vaccine components * Participation in another interventional clinical trial within 4 weeks of expected first vaccination

Treatments Being Tested

BIOLOGICAL

LBVD

Intramuscular injection into the anterolateral area of the thigh

BIOLOGICAL

Pentavalent vaccine and Inactivated Polio vaccine

Intramuscular injection into the anterolateral area of the thigh

Locations (1)

Care CT Group
Dasmariñas, Cavite, Philippines