CompletedNCT02927444Updated Apr 20, 2020

Immunogenicity and Safety Study of NBP606 in Healthy Toddlers

A Phase 3 interventional study of NBP606 and Prevnar13 in Pneumococcal Infections, sponsored by SK Chemicals Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-20.

Sponsored by SK Chemicals Co., Ltd. · Phase 3, Interventional, and Prevention

From the registry’s dates

Registered 11 months after the study started (first participant enrolled Nov 2015, registered Oct 2016).

Phase: Phase 3
Study type: Interventional
Enrollment: 462
Allocation: Randomized
Ages: 12 Months to 15 Months
Sex: All

Study summary

This study will assess the immunogenicity and safety of booster vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.

Conditions studied

Pneumococcal Infections

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In context

Pneumococcal Infections

281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.

This study's enrollment of 462 is above the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.

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Lead sponsor

SK Chemicals Co., Ltd. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Months to 15 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy infants who completed 3 doses of primary vaccination (NBP606_PCVI_III_2013), available for follow-ups during the study period.
The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

Administration of other vaccines, except the ones provided in this study, within 1month prior to booster study
Known hypersensitivity to any components of the pneumococcal vaccine
Any confirmed or suspected immunosuppressive or immunodeficient conditions
Coagulation disorder contraindicating IM(intramuscular) vaccination
Participation to another study

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 462 participants (actual)

Study arms

Experimental
NBP606
13-valent pneumococcal conjugate vaccine
Biological: NBP606
Active comparator
Prevnar13
13-valent pneumococcal conjugate vaccine
Biological: Prevnar13

Interventions

BiologicalNBP606
A single intramuscular injection into the thigh
BiologicalPrevnar13
A single intramuscular injection into the thigh

What researchers measure

Primary outcomes

Proportion of subjects with the targeted antibody concentration
Time frame: 1 month after the booster vaccination

Secondary outcomes

Geometric mean concentration ratio
Time frame: 1 month after the booster vaccination

Study locations

1 site

Clinical Research Center
Seoul, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02927444
Lead sponsor: SK Chemicals Co., Ltd.
Responsible party: Sponsor
First posted: Oct 7, 2016
Start date: Nov 4, 2015
Primary completion: Oct 26, 2017
Completion: Oct 26, 2017
Last update: Apr 20, 2020

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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