Pneumococcal InfectionsPhase 3NCT02201030
Immunogenicity and Safety Study of NBP606 in Healthy Infants
A Phase 3 study testing NBP606 and Prevnar13 in people with Pneumococcal Infections, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
This study will assess the immunogenicity and safety of primary vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations. Read more about this study
- Who is it for?
- Ages 42 to 98 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- NBP606 and Prevnar13
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 577 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Sep 2014to 21 Oct 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 98 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.
- The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.
Who cannot join
- Known hypersensitivity to any components of the pneumococcal vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient conditions
- Coagulation disorder contraindicating IM(intramuscular) vaccination
- Subject has received any licensed vaccine(not including BCG and Hepatitis B)
- Participation to another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Primary Vaccination With NBP606 in Healthy Infants
This study will assess the immunogenicity and safety of primary vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.
- Conditions
- Pneumococcal Infections
- Being tested
- NBP606, Prevnar13
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBP606Biological
A single intramuscular injection into the thigh
Prevnar13Biological
A single intramuscular injection into the thigh
| Study group | Role | What they receive |
|---|---|---|
| NBP606 | Experimental | 13-valent pneumococcal conjugate vaccine Receives: Biological: NBP606 |
| Prevnar13 | Active comparator | 13-valent pneumococcal conjugate vaccine Receives: Biological: Prevnar13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with the targeted antibody concentration
Measured: 1 month after the primary vaccination
Secondary outcomes (1)
Geometric mean concentration ratio
Measured: 1 month after the primary vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study start6 Sep 2014
- Primary completion21 Oct 2016
- Study completion21 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Confidential Investigator, Principal investigator, Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201030
- Sponsor's protocol ID
- NBP606_PCVI_III_2013
- Status last verified
- Oct 2016
- First submitted
- 16 Jul 2014
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Primary Vaccination With NBP606 in Healthy Infants
- ClinicalTrials.gov ID
- NCT02201030
- Acronym / sponsor ID
- NBP606_PCVI_III_2013
- Conditions
- Pneumococcal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2014 (actual)
- Primary completion
- 21 Oct 2016 (actual)
- Study completion
- 21 Oct 2016 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the immunogenicity and safety of primary vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBP606 | Experimental | Biological: NBP60613-valent pneumococcal conjugate vaccine |
| Prevnar13 | Active comparator | Biological: Prevnar1313-valent pneumococcal conjugate vaccine |
Who may qualify
- Ages
- 42 to 98 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.
- The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.
Key exclusion criteria (5 listed)
- Known hypersensitivity to any components of the pneumococcal vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient conditions
- Coagulation disorder contraindicating IM(intramuscular) vaccination
- Subject has received any licensed vaccine(not including BCG and Hepatitis B)
- Participation to another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBP606A single intramuscular injection into the thigh | Biological | NBP606 |
| Prevnar13A single intramuscular injection into the thigh | Biological | Prevnar13 |
Primary outcome
Proportion of subjects with the targeted antibody concentration
Time frame: 1 month after the primary vaccination
1 secondary outcome
Geometric mean concentration ratio
Time frame: 1 month after the primary vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Confidential Investigator principal investigator
Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NBP606 and Prevnar13 in people with Pneumococcal Infections, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with the targeted antibody concentration (time frame: 1 month after the primary vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.