Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Meningitis; Meningococcal Disease

Treatments: Biological: Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap); Biological: saline placebo; Biological: Meningococcal ACWY conjugate vaccine (MenACWY-CRM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00329901

V59P11

2005-005519-12 (EudraCT Number)

Details and patient eligibility

About

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

Enrollment: 1,072 patients

Sex: All

Ages: 11 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female 11-25 years old healthy subjects;
• who had received the primary immunization with a vaccine containing DT or Tdap antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry

Exclusion criteria

• previous ascertained or suspected disease caused by N. meningitidis
• previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
• serious acute, chronic or progressive disease
• history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component
• known or suspected impairment/alteration of immune function, either congenital or acquired

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,072 participants in 3 patient groups

Tdap + MenACWY-CRM

Experimental group

Description:

Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms

Treatment:

Biological: Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)

Biological: Meningococcal ACWY conjugate vaccine (MenACWY-CRM)

Tdap + saline

Experimental group

Description:

Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms

Treatment:

Biological: Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)

Biological: saline placebo

MenACWY-CRM + saline

Experimental group

Description:

Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms

Treatment:

Biological: saline placebo

Biological: Meningococcal ACWY conjugate vaccine (MenACWY-CRM)