Trial Outcomes & Findings for Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage (NCT NCT01311024)

Results Overview

Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age

Recruitment status

COMPLETED

Target enrollment

2341 participants

Primary outcome timeframe

one sampling at 3 to 7 years of age

Results posted on

2021-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	PCV-vaccinated Sibling (GSK1024850A) Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380). Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total	Control-vaccinated Sibling Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total
Overall Study STARTED	1530	811
Overall Study COMPLETED	1495	789
Overall Study NOT COMPLETED	35	22

Reasons for withdrawal

Reasons for withdrawal
Measure	PCV-vaccinated Sibling (GSK1024850A) Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380). Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total	Control-vaccinated Sibling Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total
Overall Study Protocol Violation	35	22

Baseline Characteristics

Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCV-vaccinated Sibling (GSK1024850A) n=927 Participants Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)	Control-vaccinated Sibling n=518 Participants Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)	Total n=1445 Participants Total of all reporting groups
Age, Continuous	4 years n=5 Participants	4 years n=7 Participants	4 years n=5 Participants
Sex: Female, Male Female	468 Participants n=5 Participants	257 Participants n=7 Participants	725 Participants n=5 Participants
Sex: Female, Male Male	459 Participants n=5 Participants	261 Participants n=7 Participants	720 Participants n=5 Participants

PRIMARY outcome

Timeframe: one sampling at 3 to 7 years of age

Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age

Outcome measures

Outcome measures
Measure	PCV-vaccinated Sibling (GSK1024850A) n=927 Participants Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380). Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total	Control-vaccinated Sibling n=518 Participants Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total
Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules	14.5 percentage of subjects	19.3 percentage of subjects

SECONDARY outcome

Timeframe: one sampling at 3 to 7 years of age

Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one sampling at 3 to 7 years of age

Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 years

Register follow-up up to 8 years after the vaccination of the younger sibling in the family

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 years

Register follow-up up to 8 years after the vaccination of the younger sibling in the family

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 years

Register follow-up up to 8 years after the vaccination of the younger sibling in the family

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 years

Register follow-up up to 8 years after the vaccination of the younger sibling in the family

Outcome measures

Outcome data not reported

Adverse Events

PCV-vaccinated Sibling (GSK1024850A)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control-vaccinated Sibling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arto Palmu, MD, PhD Research manager,

head of Clinical Research Unit, National Institute for Health and Welfare

Phone: +358295247910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place