Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children

NCT01545375 | Completed Phase 2 Results DMC

• 2 other identifiers: 1155972011-003956-38
• Study Type: interventional
• Target: 1,806
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.

Conditions

Infections, Streptococcal

Keywords

nasopharyngeal carriage; safety; immunogenicity; US; Pneumococcal vaccine; efficacy; Streptococcus pneumoniae; infants

Outcome Measures

Primary Outcomes (1)

• Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria

  Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). Definition of clinical AOM diagnosed and verified against AAP criteria required meeting three criteria based on the guidelines from the AAP \[AAP, 2004\], as per the judgment of a treating physician or equivalent licensed medical professional: A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND The presence of MEE indicated by any of the following: a) Bulging of tympanic membrane; b) Limited or absent mobility of tympanic membrane; c) Air-fluid level behind tympanic membrane; d) Otorrhea AND Signs or symptoms of middle-ear inflammation as indicated by either: a) Distinct erythema of tympanic membrane or b) Distinct otalgia (discomfort clearly referable to the ear\[s\] that resulted in interference with or precluded normal activity or sleep).

  Any time from 2 weeks after the administration of dose 3 up to Month 22

Secondary Outcomes (24)

• Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider

  Any time from 2 weeks after the administration of dose 3 up to Month 22

• Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria

  Any time from 2 weeks after the administration of dose 3 up to Month 22

• Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM)

  From the administration of dose 1 up to Month 22

• Time to Occurrence of Any Draining Acute Otitis Media (AOM)

  Any time from 2 weeks after the administration of dose 3 up to Month 22

• Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM)

  Any time from 2 weeks after the administration of dose 3 up to Month 22

Study Arms (2)

dPly-PhtD Group

EXPERIMENTAL

Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.

Biological: Pneumococcal vaccine GSK2189242A; Biological: Prevnar 13®; Biological: PedvaxHIB®

Control Group

PLACEBO COMPARATOR

Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.

Biological: Placebo; Biological: Prevnar 13®; Biological: PedvaxHIB®

Interventions

Pneumococcal vaccine GSK2189242A BIOLOGICAL

4 doses administered intramuscularly

dPly-PhtD Group

Placebo BIOLOGICAL

4 doses administered intramuscularly

Control Group

Prevnar 13® BIOLOGICAL

4 doses administered intramuscularly

Control Group; dPly-PhtD Group

PedvaxHIB® BIOLOGICAL

4 doses administered intramuscularly

Control Group; dPly-PhtD Group

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject who the investigator believes that their parent(s)/Legally Authorized Representative(s) (LARs) can and will comply with the requirements of the protocol.
• A male or female American Indian infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
• Voluntary, written informed consent obtained from the parents/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
• Healthy subject as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of more than 35 6/7 weeks.

You may not qualify if:

• For all infants:
• Child in care.
• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/administration of a vaccine not foreseen by the study protocol starting from 30 days before each dose and ending 30 days after each dose of study vaccines, with the exception of licensed inactivated influenza vaccines and recommended pediatric vaccines.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Previous vaccination against S. pneumoniae.
• Obstruction or anomalies of the nasopharyngeal space.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including latex.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrollment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Chinle, Arizona, 86505, United States

Location

GSK Investigational Site

Fort Defiance, Arizona, 86504, United States

Location

GSK Investigational Site

Whiteriver, Arizona, 85941, United States

Location

GSK Investigational Site

Gallup, New Mexico, 87301, United States

Location

GSK Investigational Site

Shiprock, New Mexico, 87420, United States

Location

Related Publications (1)

• Hammitt LL, Campbell JC, Borys D, Weatherholtz RC, Reid R, Goklish N, Moulton LH, Traskine M, Song Y, Swinnen K, Santosham M, O'Brien KL. Efficacy, safety and immunogenicity of a pneumococcal protein-based vaccine co-administered with 13-valent pneumococcal conjugate vaccine against acute otitis media in young children: A phase IIb randomized study. Vaccine. 2019 Dec 3;37(51):7482-7492. doi: 10.1016/j.vaccine.2019.09.076. Epub 2019 Oct 16.

  PMID: 31629570 BACKGROUND

MeSH Terms

Conditions

Streptococcal Infections

Interventions

13-valent pneumococcal vaccine; Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 6, 2012
• Study Start: May 21, 2012
• Primary Completion: July 26, 2016
• Study Completion: July 26, 2016
• Last Updated: December 27, 2019
• Results First Posted: September 12, 2017

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)