Trial Outcomes & Findings for Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With PCV10 (NCT NCT04912297)

Results Overview

Persistence of humoral immunity to vaccine- and vaccine-related pneumococcal serotypes after vaccination with PCV10. The serotype 19A specific geometric mean IgG antibody concentrations are reported as micrograms per ml with 95% confidence intervals.

Recruitment status

COMPLETED

Target enrollment

186 participants

Primary outcome timeframe

Two years following last PCV10 vaccination

Results posted on

2021-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	PCV10 2+1 Schedule Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10	PCV10 3+1 Schedule Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10
Overall Study STARTED	99	87
Overall Study COMPLETED	68	54
Overall Study NOT COMPLETED	31	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With PCV10

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCV10 2+1 Schedule n=68 Participants Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10	PCV10 3+1 Schedule n=54 Participants Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10	Total n=122 Participants Total of all reporting groups
Age, Categorical <=18 years	68 Participants n=5 Participants	54 Participants n=7 Participants	122 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	25 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	29 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment Finland	68 participants n=5 Participants	54 participants n=7 Participants	122 participants n=5 Participants

PRIMARY outcome

Timeframe: Two years following last PCV10 vaccination

Population: IgG concentrations to serotype 19A at two years following last PCV vaccination in subjects vaccinated with PCV10 with a 2+1 or 3+1 schedule

Persistence of humoral immunity to vaccine- and vaccine-related pneumococcal serotypes after vaccination with PCV10. The serotype 19A specific geometric mean IgG antibody concentrations are reported as micrograms per ml with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	PCV10 2+1 Schedule n=68 Participants Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10	PCV10 3+1 Schedule n=54 Participants Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10
Persistence of Humoral Immunity Following PCV10 Vaccination	0.32 micrograms per ml Interval 0.22 to 0.48	0.35 micrograms per ml Interval 0.23 to 0.53

Adverse Events

PCV10 2+1 Schedule

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PCV10 3+1 Schedule

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

Dr. Merit Melin, Research manager

Finnish Institute for Health and Welfare

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place