Infectious DiseasePhase 4NCT02040402
Immunogenicity of 3+1 Versus 2+1 Schedule for PCV7
A Phase 4 study testing 7-valent pneumococcal conjugated vaccine in people with Infectious Disease, run by The University of Hong Kong at 1 site in China.
Trial summary
Pneumonia is one of the most prevalent diseases in infants and children. The incidence of pneumonia in children less than 5 years old is about 34-40 cases per 1000 in Europe and America and more than 2 million children die of pneumonia annually. Read more about this study
- Who is it for?
- Ages 6 to 9 weeksHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease
- What is being tested?
- 7-valent pneumococcal conjugated vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2009to Dec 2010
- Phase
- Phase 4
- 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 6 to 9 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Chinese infants born in Hong Kong
Who cannot join
- (i)Previous administration of PCV7 or other pneumococcal vaccines
- (ii)History of immunodeficiency
- (iii)Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment
- (iv)Malignancy, other than squamous cell or basal cell skin cancer
- (v)Autoimmune disease
- (vi)History of asthma or reactive airways disease
Show all 9Show fewer
- (vii)Cardiovascular and pulmonary disorder, chronic metabolic disease (including diabetes), renal dysfunction or hemoglobinopathies requiring regular medical follow-up or hospitalization during the preceding year
- (viii)Use of immunosuppressive medication
- (ix)Receipt of blood products or immunoglobulin in the past 6 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Immunogenicity of the 3+1 Schedule and the 2+1 Schedule of 7-valent Pneumococcal Conjugated Vaccine in Young Chinese Infants
Pneumonia is one of the most prevalent diseases in infants and children. The incidence of pneumonia in children less than 5 years old is about 34-40 cases per 1000 in Europe and America and more than 2 million children die of pneumonia annually. It was reported that Streptococcus pneumoniae accounted for 13%-53% of lower respiratory tract infections in different age group of infants or children. In addition, 7%-9% of bacterial meningitis was due to Streptococcus pneumoniae infection. In addition, children infected with Streptococcus pneumoniae often transmit the pathogens to adult. As a result, it is evident that Streptococcus pneumoniae presents a heavy burden to paediatrics practice.
Vaccination of 7-valent pneumococcal conjugate vaccines is effective in preventing Streptococcus pneumonia .Routine use of PCV7 in the US has rapidly reduced rates of invasive pneumococcal disease in children. The impact of the vaccine was noted within 1 year of introduction. According to Centre for Disease Control's (CDC) Active Bacterial Core Surveillance (ABCs) the incidence of invasive pneumococcal disease among children <5 years dropped 75% from 1998/1999 to 2005; disease caused by vaccine-type strains fell 94% from 80 to 4.6 per 100,000. Currently there are two immunization schedules: manufacturer recommended the 3+1 schedule and many countries adopted a 3 dose schedule, either 3+0 or 2+1 schedules. In US, it is recommended to give three doses during infancy (scheduled at 2, 4, 6 month) plus one dose at 12-15 months (3+1 schedule). Since several studies have demonstrated that two doses may provide similar direct protection to three conjugate doses during infancy, it is recommended to give two doses during infancy plus a booster dose 12 months in some European countries including United Kingdom.
In this trial, the immunogenicity of the 3+1 schedule and the 2+1 schedule of 7-valent pneumococcal conjugated vaccine in young infants will be compared.
Read the detailed description
Streptococcus pneumonia is the most common bacterial pathogen of community-acquired pneumonia in children [1]. It may also cause meningitis, bloodstream infections and acute otitis media [1]. In 2005, WHO estimated that 1.6 million people a year die from pneumococcal disease, including up to 1 million children less than 5 years old worldwide, in particularly for infants and children less than 2 years old [1]. Most of the death occur in developing countries [2, 3]. Case fatality ratios are highest for invasive infections and range from 5-20% for bacteremia to 40-50% for meningitis. Among meningitis survivors, long-term neurologic sequelae occur in 25-56% of cases [4].
Most pneumococcal infections can be treated effectively with antibiotics, although meningitis still often results in devastating outcomes. Over the last 20 years, the emergence of antimicrobial resistance among S. pneumoniae complicates treatment of infections. Penicillin and co-trimoxazole resistance are common in many parts of the world, including China [5-9]. Multidrug resistance has also emerged and is best documented in industrialized countries. Treatment failures due to resistance have been documented for acute otitis media, meningitis and bloodstream infections [5-6].
Currently two pneumococcal vaccines are licensed and available. One is the 23-valent pneumococcal polysaccharide vaccine (PPV23). However it is not recommended for children less than 2 year old. Another one is the 7-valent pneumococcal conjugate vaccine (PCV7) which can be used for children 6 weeks to 24 months of age. PCV7 includes the capsular polysaccharide of 7 serotypes (4,6B, 9V, 14, 18C, 19F, 23F), each coupled to a nontoxic variant of diphtheria toxin, CRM197. The vaccine contains 2 μg each of capsular polysaccharide from serotypes 4,9V, 14, 19F and 23F; 2 μg of oligosaccharide from 18C; 4 μg of capsular polysaccharide of 6B; 20 μg of CRM197; and 0.125 mg of aluminum/0.5 ml dose as an aluminum phosphate adjuvant [10].
Since the licensure of the PCV7 in 2000, it is being widely used for infants and toddlers in most of the developed countries. It has been demonstrated that PCV7 provide great protections for pneumococcal invasive disease (meningitis, bloodstream infections), pneumonia and otitis media [11, 12]. Routine use of PCV7 in the US has rapidly reduced rates of invasive pneumococcal disease in children. The impact of the vaccine was noted within 1 year of introduction. According to CDC's Active Bacterial Core Surveillance (ABCs) the incidence of invasive pneumococcal disease among children <5 years dropped 75% from 1998/1999 to 2005; disease caused by vaccine-type strains fell 94% from 80 to 4.6 per 100,000 [13, 14]. A multi-centre study of hospitalized patients found that 77% fewer cases in children <2 years were caused by vaccine serotypes in 2002 compared to the average number of cases during 1994-2000 [15]. Surveillance data on vaccine impact from outside the US are currently limited. Data from Calgary, Canada showed a 93% reduction in vaccine-type invasive disease in children <2 years of age [16]. In Australia, the rate of vaccine-type invasive pneumococcal disease reduced by 78% between 2002 and 2006 in children aged under 2 years [17]. In US, it was also found that one or more doses of PCV7 was 96% effective against invasive disease in healthy children, 81% effective in children with comorbid medical conditions and 76% effective overall against disease caused by strains resistant to penicillin [18]. PCV7 use also appears to be reducing non-invasive pneumococcal infections in the US, including otitis media and pneumonia [19-22].
Currently there are two immunization schedules: the 3+1 and the 2+1 schedules. In US, it is recommended to give three doses during infancy (scheduled at 2, 4, 6 month) plus one dose at 12-15 months (3+1 schedule). Since several studies have demonstrated that two doses may provide similar direct protection to three conjugate doses during infancy, it is recommended to give two doses during infancy plus a booster dose 12 months in some European countries including UK [23, 24].
In China, a recent serogroup distribution study in out-patient department (OPD) patients with acute upper respiratory infections showed that coverage with PCV7 was about 55% for nasopharyngeal carriage pneumococci isolates, and 75% for the penicillin-nonsusceptible pneumococci isolates from 2000 to 2005 [25], suggesting that PCV7 is effective for preventing pneumococcal infections. Since PCV7 was only licensed in China by May of 2008, there is no data for the effectiveness. For immunization schedule, the manufacturer of PCV7 (Wyeth Pharmaceuticals Inc) recommends to use 3+1 schedule in China as that in US. However, China may NOT have enough resources for mass vaccination as a developing country because PCV7 is very expensive. Therefore, generating our own data in China and developing an alternative immunization schedule, such as 2+1, may have great advantage to save more lives by using a limited resource.
- Conditions
- Infectious Disease
- Being tested
- 7-valent pneumococcal conjugated vaccine
- Keywords
- Comparison of pneumococcal conjugated vaccine regimes
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-valent pneumococcal conjugated vaccineBiological
Pneumococcal vaccine 3+1 and 2+1 schedule comparison
7-valent pneumococcal conjugated vaccineBiological
3+1 doses vs 2+1 doses
| Study group | Role | What they receive |
|---|---|---|
| 4-Dose Regimen | Active comparator | 3+1 schedule of 7-valent pneumococcal conjugated vaccine:
Infants who are randomized for 3+1 schedule will be administrated one dose of PCV7 at the age of 2 months old, 4months old and 6 months old. A booster dose will be administrated at the age of 12 months old.
Infants will be followed up for 12-16 months starting from vaccination of first dose. There is no restriction on the use of other medications before or during the follow-up period. Receives: Biological: 7-valent pneumococcal conjugated vaccine |
| 3-Dose Regimen | Active comparator | 2+1 schedule of 7-valent pneumococcal conjugated vaccine:
Infants who are randomized for 2+1 schedule will be administrated with one dose of PCV7 at the age of 2 months old and 4months old. A booster dose will be administrated at the age of 12 months old.
Infants will be followed up for 12-16 months starting from vaccination of first dose. There is no restriction on the use of other medications before or during the follow-up period. Receives: Biological: 7-valent pneumococcal conjugated vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological response in terms of geometric mean titres after the primary dose series and booster for the 2+1 and 3+1 schedules.
Measured: An average of one month post vaccination
Secondary outcomes (1)
Proportion of infants with Immunoglobulin G concentrations above 0.35ug/ml to the 7 serotypes
Measured: An average of one month post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Society for the Relief of Disabled Children, Hong Kong
- Responsible party
- Principal investigator, Lau Yu Lung, The University of Hong Kong
- Investigators
- Yu-lung LAU, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040402
- Sponsor's protocol ID
- UW 09-024
- Status last verified
- Jan 2014
- First submitted
- 19 Dec 2013
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pneumococcal conjugate vaccine for childhood immunization--WHO position paper. Wkly Epidemiol Rec. 2007 Mar 23;82(12):93-104. No abstract available. English, French.
PubMed 17380597Black RE, Morris SS, Bryce J. Where and why are 10 million children dying every year? Lancet. 2003 Jun 28;361(9376):2226-34. doi: 10.1016/S0140-6736(03)13779-8.
PubMed 12842379Bryce J, Boschi-Pinto C, Shibuya K, Black RE; WHO Child Health Epidemiology Reference Group. WHO estimates of the causes of death in children. Lancet. 2005 Mar 26-Apr 1;365(9465):1147-52. doi: 10.1016/S0140-6736(05)71877-8.
PubMed 15794969Goetghebuer T, West TE, Wermenbol V, Cadbury AL, Milligan P, Lloyd-Evans N, Adegbola RA, Mulholland EK, Greenwood BM, Weber MW. Outcome of meningitis caused by Streptococcus pneumoniae and Haemophilus influenzae type b in children in The Gambia. Trop Med Int Health. 2000 Mar;5(3):207-13. doi: 10.1046/j.1365-3156.2000.00535.x.
PubMed 10747284Mera RM, Miller LA, Daniels JJ, Weil JG, White AR. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States over a 10-year period: Alexander Project. Diagn Microbiol Infect Dis. 2005 Mar;51(3):195-200. doi: 10.1016/j.diagmicrobio.2004.10.009.
PubMed 15766606Whitney CG, Farley MM, Hadler J, Harrison LH, Lexau C, Reingold A, Lefkowitz L, Cieslak PR, Cetron M, Zell ER, Jorgensen JH, Schuchat A; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States. N Engl J Med. 2000 Dec 28;343(26):1917-24. doi: 10.1056/NEJM200012283432603.
PubMed 11136262Kyaw MH, Lynfield R, Schaffner W, Craig AS, Hadler J, Reingold A, Thomas AR, Harrison LH, Bennett NM, Farley MM, Facklam RR, Jorgensen JH, Besser J, Zell ER, Schuchat A, Whitney CG; Active Bacterial Core Surveillance of the Emerging Infections Program Network. Effect of introduction of the pneumococcal conjugate vaccine on drug-resistant Streptococcus pneumoniae. N Engl J Med. 2006 Apr 6;354(14):1455-63. doi: 10.1056/NEJMoa051642.
PubMed 16598044Song JH, Lee NY, Ichiyama S, Yoshida R, Hirakata Y, Fu W, Chongthaleong A, Aswapokee N, Chiu CH, Lalitha MK, Thomas K, Perera J, Yee TT, Jamal F, Warsa UC, Vinh BX, Jacobs MR, Appelbaum PC, Pai CH. Spread of drug-resistant Streptococcus pneumoniae in Asian countries: Asian Network for Surveillance of Resistant Pathogens (ANSORP) Study. Clin Infect Dis. 1999 Jun;28(6):1206-11. doi: 10.1086/514783.
PubMed 10451154Yao K, Shen X, Yul S, Lu Q, Deng L, Ye Q, Zhang H, Deng Q, Hu Y, Yang Y. Antimicrobial resistance and serotypes of nasopharyngeal strains of Streptococcus pneumoniae in Chinese children with acute respiratory infections. J Int Med Res. 2007 Mar-Apr;35(2):253-67. doi: 10.1177/147323000703500210.
PubMed 17542413Murray D, Jackson C. A conjugate vaccine for the prevention of pediatric pneumococcal disease. Mil Med. 2002 Aug;167(8):671-7.
PubMed 12188240Trotter CL, McVernon J, Ramsay ME, Whitney CG, Mulholland EK, Goldblatt D, Hombach J, Kieny MP; SAGE subgroup. Optimising the use of conjugate vaccines to prevent disease caused by Haemophilus influenzae type b, Neisseria meningitidis and Streptococcus pneumoniae. Vaccine. 2008 Aug 18;26(35):4434-45. doi: 10.1016/j.vaccine.2008.05.073. Epub 2008 Jun 17.
PubMed 18617296Trotter CL, Greenwood BM. Meningococcal carriage in the African meningitis belt. Lancet Infect Dis. 2007 Dec;7(12):797-803. doi: 10.1016/S1473-3099(07)70288-8.
PubMed 18045562Whitney CG, Farley MM, Hadler J, Harrison LH, Bennett NM, Lynfield R, Reingold A, Cieslak PR, Pilishvili T, Jackson D, Facklam RR, Jorgensen JH, Schuchat A; Active Bacterial Core Surveillance of the Emerging Infections Program Network. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med. 2003 May 1;348(18):1737-46. doi: 10.1056/NEJMoa022823.
PubMed 12724479Centers for Disease Control and Prevention (CDC). Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease--United States, 1998-2003. MMWR Morb Mortal Wkly Rep. 2005 Sep 16;54(36):893-7.
PubMed 16163262Kaplan SL, Mason EO Jr, Wald ER, Schutze GE, Bradley JS, Tan TQ, Hoffman JA, Givner LB, Yogev R, Barson WJ. Decrease of invasive pneumococcal infections in children among 8 children's hospitals in the United States after the introduction of the 7-valent pneumococcal conjugate vaccine. Pediatrics. 2004 Mar;113(3 Pt 1):443-9. doi: 10.1542/peds.113.3.443.
PubMed 14993532
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Immunogenicity of the 3+1 Schedule and the 2+1 Schedule of 7-valent Pneumococcal Conjugated Vaccine in Young Chinese Infants
- ClinicalTrials.gov ID
- NCT02040402
- Acronym / sponsor ID
- UW 09-024
- Conditions
- Infectious Disease
- Keywords
- Comparison of pneumococcal conjugated vaccine regimes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Society for the Relief of Disabled Children, Hong Kong
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Jan 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.
Pneumonia is one of the most prevalent diseases in infants and children. The incidence of pneumonia in children less than 5 years old is about 34-40 cases per 1000 in Europe and America and more than 2 million children die of pneumonia annually. It was reported that Streptococcus pneumoniae accounted for 13%-53% of lower respiratory tract infections in different age group of infants or children. In addition, 7%-9% of bacterial meningitis was due to Streptococcus pneumoniae infection. In addition, children infected with Streptococcus pneumoniae often transmit the pathogens to adult. As a result, it is evident that Streptococcus pneumoniae presents a heavy burden to paediatrics practice.
Vaccination of 7-valent pneumococcal conjugate vaccines is effective in preventing Streptococcus pneumonia .Routine use of PCV7 in the US has rapidly reduced rates of invasive pneumococcal disease in children. The impact of the vaccine was noted within 1 year of introduction. According to Centre for Disease Control's (CDC) Active Bacterial Core Surveillance (ABCs) the incidence of invasive pneumococcal disease among children <5 years dropped 75% from 1998/1999 to 2005; disease caused by vaccine-type strains fell 94% from 80 to 4.6 per 100,000. Currently there are two immunization schedules: manufacturer recommended the 3+1 schedule and many countries adopted a 3 dose schedule, either 3+0 or 2+1 schedules. In US, it is recommended to give three doses during infancy (scheduled at 2, 4, 6 month) plus one dose at 12-15 months (3+1 schedule). Since several studies have demonstrated that two doses may provide similar direct protection to three conjugate doses during infancy, it is recommended to give two doses during infancy plus a booster dose 12 months in some European countries including United Kingdom.
In this trial, the immunogenicity of the 3+1 schedule and the 2+1 schedule of 7-valent pneumococcal conjugated vaccine in young infants will be compared.
Detailed description
Streptococcus pneumonia is the most common bacterial pathogen of community-acquired pneumonia in children [1]. It may also cause meningitis, bloodstream infections and acute otitis media [1]. In 2005, WHO estimated that 1.6 million people a year die from pneumococcal disease, including up to 1 million children less than 5 years old worldwide, in particularly for infants and children less than 2 years old [1]. Most of the death occur in developing countries [2, 3]. Case fatality ratios are highest for invasive infections and range from 5-20% for bacteremia to 40-50% for meningitis. Among meningitis survivors, long-term neurologic sequelae occur in 25-56% of cases [4].
Most pneumococcal infections can be treated effectively with antibiotics, although meningitis still often results in devastating outcomes. Over the last 20 years, the emergence of antimicrobial resistance among S. pneumoniae complicates treatment of infections. Penicillin and co-trimoxazole resistance are common in many parts of the world, including China [5-9]. Multidrug resistance has also emerged and is best documented in industrialized countries. Treatment failures due to resistance have been documented for acute otitis media, meningitis and bloodstream infections [5-6].
Currently two pneumococcal vaccines are licensed and available. One is the 23-valent pneumococcal polysaccharide vaccine (PPV23). However it is not recommended for children less than 2 year old. Another one is the 7-valent pneumococcal conjugate vaccine (PCV7) which can be used for children 6 weeks to 24 months of age. PCV7 includes the capsular polysaccharide of 7 serotypes (4,6B, 9V, 14, 18C, 19F, 23F), each coupled to a nontoxic variant of diphtheria toxin, CRM197. The vaccine contains 2 μg each of capsular polysaccharide from serotypes 4,9V, 14, 19F and 23F; 2 μg of oligosaccharide from 18C; 4 μg of capsular polysaccharide of 6B; 20 μg of CRM197; and 0.125 mg of aluminum/0.5 ml dose as an aluminum phosphate adjuvant [10].
Since the licensure of the PCV7 in 2000, it is being widely used for infants and toddlers in most of the developed countries. It has been demonstrated that PCV7 provide great protections for pneumococcal invasive disease (meningitis, bloodstream infections), pneumonia and otitis media [11, 12]. Routine use of PCV7 in the US has rapidly reduced rates of invasive pneumococcal disease in children. The impact of the vaccine was noted within 1 year of introduction. According to CDC's Active Bacterial Core Surveillance (ABCs) the incidence of invasive pneumococcal disease among children <5 years dropped 75% from 1998/1999 to 2005; disease caused by vaccine-type strains fell 94% from 80 to 4.6 per 100,000 [13, 14]. A multi-centre study of hospitalized patients found that 77% fewer cases in children <2 years were caused by vaccine serotypes in 2002 compared to the average number of cases during 1994-2000 [15]. Surveillance data on vaccine impact from outside the US are currently limited. Data from Calgary, Canada showed a 93% reduction in vaccine-type invasive disease in children <2 years of age [16]. In Australia, the rate of vaccine-type invasive pneumococcal disease reduced by 78% between 2002 and 2006 in children aged under 2 years [17]. In US, it was also found that one or more doses of PCV7 was 96% effective against invasive disease in healthy children, 81% effective in children with comorbid medical conditions and 76% effective overall against disease caused by strains resistant to penicillin [18]. PCV7 use also appears to be reducing non-invasive pneumococcal infections in the US, including otitis media and pneumonia [19-22].
Currently there are two immunization schedules: the 3+1 and the 2+1 schedules. In US, it is recommended to give three doses during infancy (scheduled at 2, 4, 6 month) plus one dose at 12-15 months (3+1 schedule). Since several studies have demonstrated that two doses may provide similar direct protection to three conjugate doses during infancy, it is recommended to give two doses during infancy plus a booster dose 12 months in some European countries including UK [23, 24].
In China, a recent serogroup distribution study in out-patient department (OPD) patients with acute upper respiratory infections showed that coverage with PCV7 was about 55% for nasopharyngeal carriage pneumococci isolates, and 75% for the penicillin-nonsusceptible pneumococci isolates from 2000 to 2005 [25], suggesting that PCV7 is effective for preventing pneumococcal infections. Since PCV7 was only licensed in China by May of 2008, there is no data for the effectiveness. For immunization schedule, the manufacturer of PCV7 (Wyeth Pharmaceuticals Inc) recommends to use 3+1 schedule in China as that in US. However, China may NOT have enough resources for mass vaccination as a developing country because PCV7 is very expensive. Therefore, generating our own data in China and developing an alternative immunization schedule, such as 2+1, may have great advantage to save more lives by using a limited resource.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-Dose Regimen | Active comparator | Biological: 7-valent pneumococcal conjugated vaccine3+1 schedule of 7-valent pneumococcal conjugated vaccine: Infants who are randomized for 3+1 schedule will be administrated one dose of PCV7 at the age of 2 months old, 4months old and 6 months old. A booster dose will be administrated at the age of 12 months old. Infants will be followed up for 12-16 months starting from vaccination of first dose. There is no restriction on the use of other medications before or during the follow-up period. |
| 3-Dose Regimen | Active comparator | Biological: 7-valent pneumococcal conjugated vaccine2+1 schedule of 7-valent pneumococcal conjugated vaccine: Infants who are randomized for 2+1 schedule will be administrated with one dose of PCV7 at the age of 2 months old and 4months old. A booster dose will be administrated at the age of 12 months old. Infants will be followed up for 12-16 months starting from vaccination of first dose. There is no restriction on the use of other medications before or during the follow-up period. |
Who may qualify
- Ages
- 6 to 9 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Chinese infants born in Hong Kong
Key exclusion criteria (9 listed)
- (i)Previous administration of PCV7 or other pneumococcal vaccines
- (ii)History of immunodeficiency
- (iii)Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment
- (iv)Malignancy, other than squamous cell or basal cell skin cancer
- (v)Autoimmune disease
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 |
|---|---|---|
| 7-valent pneumococcal conjugated vaccinePneumococcal vaccine 3+1 and 2+1 schedule comparison | Biological | 3-Dose Regimen |
| 7-valent pneumococcal conjugated vaccine3+1 doses vs 2+1 doses | Biological | 4-Dose Regimen |
Primary outcome
Serological response in terms of geometric mean titres after the primary dose series and booster for the 2+1 and 3+1 schedules.
Time frame: An average of one month post vaccination
1 secondary outcome
Proportion of infants with Immunoglobulin G concentrations above 0.35ug/ml to the 7 serotypes
Time frame: An average of one month post 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 Jan 2014.
- Background: PubMed 17380597Pneumococcal conjugate vaccine for childhood immunization--WHO position paper. Wkly Epidemiol Rec. 2007 Mar 23;82(12):93-104. No abstract available. English, French.
- Background: PubMed 12842379Black RE, Morris SS, Bryce J. Where and why are 10 million children dying every year? Lancet. 2003 Jun 28;361(9376):2226-34. doi: 10.1016/S0140-6736(03)13779-8.
- Background: PubMed 15794969Bryce J, Boschi-Pinto C, Shibuya K, Black RE; WHO Child Health Epidemiology Reference Group. WHO estimates of the causes of death in children. Lancet. 2005 Mar 26-Apr 1;365(9465):1147-52. doi: 10.1016/S0140-6736(05)71877-8.
- Background: PubMed 10747284Goetghebuer T, West TE, Wermenbol V, Cadbury AL, Milligan P, Lloyd-Evans N, Adegbola RA, Mulholland EK, Greenwood BM, Weber MW. Outcome of meningitis caused by Streptococcus pneumoniae and Haemophilus influenzae type b in children in The Gambia. Trop Med Int Health. 2000 Mar;5(3):207-13. doi: 10.1046/j.1365-3156.2000.00535.x.
- Background: PubMed 15766606Mera RM, Miller LA, Daniels JJ, Weil JG, White AR. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States over a 10-year period: Alexander Project. Diagn Microbiol Infect Dis. 2005 Mar;51(3):195-200. doi: 10.1016/j.diagmicrobio.2004.10.009.
- Background: PubMed 11136262Whitney CG, Farley MM, Hadler J, Harrison LH, Lexau C, Reingold A, Lefkowitz L, Cieslak PR, Cetron M, Zell ER, Jorgensen JH, Schuchat A; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States. N Engl J Med. 2000 Dec 28;343(26):1917-24. doi: 10.1056/NEJM200012283432603.
- Background: PubMed 16598044Kyaw MH, Lynfield R, Schaffner W, Craig AS, Hadler J, Reingold A, Thomas AR, Harrison LH, Bennett NM, Farley MM, Facklam RR, Jorgensen JH, Besser J, Zell ER, Schuchat A, Whitney CG; Active Bacterial Core Surveillance of the Emerging Infections Program Network. Effect of introduction of the pneumococcal conjugate vaccine on drug-resistant Streptococcus pneumoniae. N Engl J Med. 2006 Apr 6;354(14):1455-63. doi: 10.1056/NEJMoa051642.
- Background: PubMed 10451154Song JH, Lee NY, Ichiyama S, Yoshida R, Hirakata Y, Fu W, Chongthaleong A, Aswapokee N, Chiu CH, Lalitha MK, Thomas K, Perera J, Yee TT, Jamal F, Warsa UC, Vinh BX, Jacobs MR, Appelbaum PC, Pai CH. Spread of drug-resistant Streptococcus pneumoniae in Asian countries: Asian Network for Surveillance of Resistant Pathogens (ANSORP) Study. Clin Infect Dis. 1999 Jun;28(6):1206-11. doi: 10.1086/514783.
- Background: PubMed 17542413Yao K, Shen X, Yul S, Lu Q, Deng L, Ye Q, Zhang H, Deng Q, Hu Y, Yang Y. Antimicrobial resistance and serotypes of nasopharyngeal strains of Streptococcus pneumoniae in Chinese children with acute respiratory infections. J Int Med Res. 2007 Mar-Apr;35(2):253-67. doi: 10.1177/147323000703500210.
- Background: PubMed 12188240Murray D, Jackson C. A conjugate vaccine for the prevention of pediatric pneumococcal disease. Mil Med. 2002 Aug;167(8):671-7.
- Background: PubMed 18617296Trotter CL, McVernon J, Ramsay ME, Whitney CG, Mulholland EK, Goldblatt D, Hombach J, Kieny MP; SAGE subgroup. Optimising the use of conjugate vaccines to prevent disease caused by Haemophilus influenzae type b, Neisseria meningitidis and Streptococcus pneumoniae. Vaccine. 2008 Aug 18;26(35):4434-45. doi: 10.1016/j.vaccine.2008.05.073. Epub 2008 Jun 17.
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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.
Yu-lung LAU, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 7-valent pneumococcal conjugated vaccine in people with Infectious Disease, run by The University of Hong Kong at 1 site in China.
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 1 inclusion and 9 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 Jan 2014. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Serological response in terms of geometric mean titres after the primary dose series and booster for the 2+1 and 3+1 schedules. (time frame: An average of one month post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02040402, which also lists 25 linked publications.
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 Jan 2014.