Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults

The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.

开始日期2014-05-01

申办/合作机构

Green Cross Co., Ltd.

CTRI/2013/09/004032

/ Completed临床4期

A Multicentre, Open label, randomised, phase-IV study to evaluate the immunogenicity & safety of a single booster dose of BEs Tetanus Diphtheria (Td) vaccine (adsorbed) administered to healthy Indian children â?¥7 years, Adolescents and Adults who received primary immunisation as compared with a marketed Diphtheria and Tetanus (Td) vaccine - None

开始日期2013-10-03

申办/合作机构

Biological E Limited.

NCT01402713

/ Completed临床2/3期

Randomized, Double Blind, Multicenter, Phase II/III Study to Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children

The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children

开始日期2011-08-01

申办/合作机构

Green Cross Co., Ltd.

100 项与 Diphtheria-tetanus vaccine(Green Cross) 相关的临床结果

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100 项与 Diphtheria-tetanus vaccine(Green Cross) 相关的转化医学

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100 项与 Diphtheria-tetanus vaccine(Green Cross) 相关的专利（医药）

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项与 Diphtheria-tetanus vaccine(Green Cross) 相关的文献（医药）

2025-11-01·Journal of Pediatric Nursing-Nursing Care of Children & Families

Reducing vaccination pain using a multidermatomal or deltoid region buzzy® applications versus control: A randomized controlled study

Article

作者: Sahiner, Nejla Canbulat ; Ates Besirik, Selda ; Kirboga, Ziyaeddin ; Turgut, Mehmet Alperen ; Baxter, Amy L

BACKGROUND:

Pain with injections negatively affects children and their parents and may contribute to vaccine refusal. A cold and vibration device shown to reduce immunization pain when placed in the nerve pathway proximal to the injection may be more effective when placed medially activating multiple dermatomes.

AIM:

This study aimed to compare the effects of the multidermatomal and deltoid region applications of the Buzzy® device versus control on immunization pain.

METHODS:

This prospective randomized controlled study. This study was conducted with 90 13-year-olds who met the inclusion criteria and were scheduled for Td (adult diphtheria-tetanus) vaccinations. The children were randomly divided into the multidermatomal placement group, the deltoid region group, and the control group. The Interview and Observation Form and the Wong-Baker FACES Pain Rating Scale (0-10) were used to collect data. The Wong-Baker FACES Pain Rating Scale was administrated to and filled out by the children, their parents, and the observers. Descriptive statistics, one-way analysis of variance (ANOVA), Kruskal-Wallis, and Pearson's Chi-Squared were used to analyze the data with significance at p < 0.05.

FINDINGS:

The pain reported with multidermatomal Buzzy application (0.33±0.75) was significantly lower than deltoid Buzzy placement (1.86±1.57), which was significantly lower than control group pain(5.06±1.14)(p < 0.001). With multidermatomal placement, the injection was painless for 25/30 compared to 1/30 in the control group, relative risk of pain of 0.0069(95 %CI 0.0008-0.0630), p < 0.0001.

CONCLUSIONS:

Multidermatomal application of cold and vibration during vaccine administration to children is more effective than deltoid application for pain relief and was painless over 80 % of the time.

PRACTICE IMPLICATIONS:

The Buzzy® device in either a single dermatome (deltoid) or multiple dermatomes were effective in reducing pain associated with the injection of the Td vaccine to 13-year-old children.

CLINICAL TRIAL REGISTRATION NUMBER:

Registered on https://clinicaltrials.gov/ (NCT06566378).

2025-07-01·JOURNAL OF INFECTION

Immune impacts of infant whole-cell and acellular pertussis vaccination on co-administered vaccines

Article

作者: Curtis, Nigel ; O'Sullivan, Michael ; McAlister, Sonia ; McIntyre, Peter B ; Totterdell, James ; Marsh, Julie A ; Jones, Mark ; Richmond, Peter C ; Waddington, Claire S ; Wadia, Ushma ; Estcourt, Marie J ; Gold, Michael ; Wood, Nicholas ; Campbell, Dianne E ; Snelling, Tom ; Perrett, Kirsten P ; Holt, Patrick G ; Pérez Chacón, Gladymar

OBJECTIVES:

We compared the effect of a heterologous wP/aP/aP primary series (hereafter mixed wP/aP) versus a homologous aP/aP/aP primary schedule (hereafter aP-only) on antibody responses to co-administered vaccine antigens in infants and toddlers.

METHODS:

We randomised Australian infants in a 1:1 ratio to receive either a mixed wP/aP schedule (pentavalent diphtheria-tetanus-wP-hepatitis B-Haemophilus influenzae type b; DTwP-HepB-Hib vaccine at 6 weeks old, followed by hexavalent DTaP-inactivated poliovirus vaccine (IPV)-HepB-Hib vaccine at 4 and 6 months old) or aP-only priming doses of hexavalent DTaP-IPV-HepB-Hib vaccine at the same ages. All infants received 13-valent pneumococcal conjugate vaccine (13vPCV) at 6 weeks, 4 and 12 months of age and DTaP-IPV and Hib vaccine boosters at 18 months. We assessed whether the wP/aP schedule is non-inferior to the aP-only schedule for co-administered vaccine antigens (geometric mean ratio [GMR] >2/3).

REGISTRATION:

ACTRN12617000065392p.

RESULTS:

Between March 2018 and January 2020, 150 infants were randomised (75 per arm). Responses to all 13vPCV serotypes and Hib-PRP at 6, 7, 18, and 19 months old, as well as HBsAg at 6 and 7 months old, were non-inferior (>90% probability).

CONCLUSION:

A mixed wP/aP schedule resulted in non-inferior IgG responses to co-administered vaccine antigens compared to the standard aP-only schedule for pertussis primary immunisation.

2025-01-01·Annals of African Medicine

Health Facility Capacity and Health-care Worker Knowledge, Attitudes, and Practices of Hepatitis B Vaccine Birth-dose and Maternal Tetanus-Diphtheria Vaccine Administration in Nigeria: A Baseline Assessment

Article

作者: Shuaib, Faisal ; Sandhu, Hardeep S. ; Mohammed, Yahaya ; Ismail, Binta Aduke ; Michael, Charles A. ; Bolu, Omotayo O. ; Okposen, Bassey Bassey ; Adewole, Adefisoye ; Isa, Abdullahi ; Asekun, Adeyelu ; Ugwu, George O. ; Waziri, Ndadilnasiya E. ; Okeke, Lilian Akudo ; Fadahunsi, Rhoda ; Minta, Anna ; Obi, Emmanuel I. ; Ugbenyo, Gideon ; Bahuli, Abubakar U. ; Simple, Edwin ; Nwokoro, Ugochukwu Uzoechina ; Bashir, Sulaiman Saidu ; Ikwe, Hadley ; Uba, Belinda V. ; Vasumu, James J. ; Kanu, Florence ; Wisdom, Margeret Osas ; Tohme, Rania A. ; Freeland, Catherine

Background::

Hepatitis B virus (HBV) and neonatal tetanus infections remain endemic in Nigeria despite the availability of safe, effective vaccines. We aimed to determine health facilities’ capacity for hepatitis B vaccine birth dose (HepB-BD) and maternal tetanus-diphtheria (Td) vaccination and to assess knowledge, attitudes, and practices of HepB-BD and maternal Td vaccine administration among health facility staff in Nigeria.

Materials and Methods::

This was a cross-sectional study assessing public primary and secondary health facilities in Adamawa and Enugu States. A multistage sampling approach was used to select 40 facilities and 79 health-care workers (HCWs) from each state. A structured facility assessment tool and standardized questionnaire evaluated facility characteristics and HCW knowledge, attitudes, and practices related to HepB-BD and maternal Td vaccination. Frequencies and proportions were reported as descriptive statistics.

Results::

The survey of 80 facilities revealed that 73.8% implemented HepB-BD and maternal Td vaccination policies. HepB-BD was administered within 24 h of birth at 61.3% of facilities and at all times at 57.5%. However, administration seldom occurred in labor and delivery (35%) or maternity wards (16.3%). Nearly half of the facilities (46.3%) had HCWs believing there were contraindications to HepB-BD vaccination. Among 158 HCWs, 26.5% believed tetanus could be transmitted through unprotected sex, prevented by vaccination at birth (46.1%), or by avoiding sharing food and utensils. 65% of HCWs knew HBV infection had the worst outcome for newborns.

Conclusions::

The limited implementation of national policies on HepB-BD and maternal Td vaccination, coupled with knowledge gaps among HCWs, pose significant challenges to timely vaccination, necessitating interventions to address these gaps.

100 项与 Diphtheria-tetanus vaccine(Green Cross) 相关的药物交易

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