Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

STATUS

Recruiting
End date

Jul 22, 2024
participants needed

1200
sponsor

GlaxoSmithKline

Send

Updated on 12 May 2022

See if I qualify

vaccination

pneumococcal

varivax

conjugate vaccine

hiberix

bexsero

Accepts healthy volunteers

Summary

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccines(RIV).

Description

This study will be divided into 3 timepoints:

Epoch 1- Primary- From day 1 to day 301
Epoch 2-Secondary-From day 301 to day 331
Epoch 3-Safety follow up -From day 331 to study end (day 661) In addition to receiving the study vaccines, infants will also receive non-study vaccines such as Diphtheria, tetanus toxoids and acellular pertussis adsorbed vaccine (DTPa, Infanrix) and Haemophilus influenzae type b Conjugate Vaccine (Hib, Hiberix), to ease the disruption to the standard infant vaccine schedule caused by participating in this study.

Details

Condition	Infections, Meningococcal
Treatment	Prevnar13, Rotarix, Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ), Pediarix, Hiberix, M-M-R II, Varivax, Varivax, Placebo (saline water)
Clinical Study Identifier	NCT03621670
Sponsor	GlaxoSmithKline
Last Modified on	12 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	All subjects must satisfy all the following criteria at study entry
	Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the eDiary, return for follow-up visits)
	Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure
	A male or female between, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination
	Healthy subjects as established by medical history and clinical examination before entering into the study
	Born full-term (i.e. after a gestation period of ≥ 38 weeks)
Exclusion Criteria
	If any exclusion criterion applies, the subject must not be included in the
	study
	• Child in care
	Each subject must not have
	Progressive, unstable or uncontrolled clinical conditions
	Hypersensitivity, including allergy to any component of vaccines, medicinal product or medical equipment whose use is foreseen in this study
	Hypersensitivity to latex
	Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
	Abnormal function of the immune system resulting from
	Clinical conditions
	Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth
	Administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth
	Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes)
	Received immunoglobulins or any blood products from birth
	Received an investigational or non-registered medicinal product from birth
	Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
	Neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions)
	Congenital or peripartum disorders resulting in a chronic condition (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders)
	Study personnel as an immediate family or household member
	Current or previous, confirmed or suspected disease caused by N. meningitidis
	Household contact with and/or intimate exposure from birth to an individual with laboratory confirmed N. meningitidis and/or Streptococcus pneumoniae infection or colonization
	Previous administration of meningococcal B or pneumococcal vaccine at any time prior to informed consent
	Received a dose of DTPa-HBV-IPV, HRV, MMR, VV and/or Hib at any time prior to informed consent. Receipt of one dose of HBV up to 4 weeks prior to informed con-sent is allowed
	Serious chronic illness
	Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS)

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Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants